Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001217998
Ethics application status
Approved
Date submitted
5/10/2011
Date registered
25/11/2011
Date last updated
30/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Swallowing, nutritional status, and markers of inflammation and oxidative stress in a Children's Hospital.
Scientific title
Assessment of swallowing, nutritional status, and markers of inflammation and oxidative stress in children and adolescents with cystic fibrosis.
Secondary ID [1] 273168 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic fibrosis 278918 0
Condition category
Condition code
Human Genetics and Inherited Disorders 279097 279097 0 0
Cystic fibrosis
Diet and Nutrition 279098 279098 0 0
Other diet and nutrition disorders
Inflammatory and Immune System 279409 279409 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cystic Fibrosis is a genetic disease characterized by the secretion of thick mucus from submucosal glands. With the clogged ducts, the lungs are more susceptible to infection and inflammation. The lung disease unbalances the concentrations of oxidants and antioxidants and promotes chronic inflammation, resulting in cell damage. The overgeneration of reactive oxygen species and the depletion of antioxidants lead to oxidative stress in cystic fibrosis patients. Excessive production of reactive oxygen species takes place principally due to abnormalities in the ion transport in the respiratory tract. Associated with this fact, it has been observed that patients with cystic fibrosis may have dysphagia, due to the relationship between swallowing and breathing, and dysphagia favors bronchospasm, pneumonia and chronic lung infections. Cross-section study for two years. In this study will be assessable association between lung function, nutritional status, swallowing and oxidative stress and inflammatory markers such as reduced glutathione (GSH), glutathione peroxidase (GPx), catalase (CAT) and activity of the myeloperoxidase enzyme (MPO), carbonyl protein (CP), thiobarbituric acid reactive substances (TBARS), nitric oxide metabolites (NOx), C-reactive protein (CRP), adenosine deaminase (ADA), tumor necrosis factor alpha (TNF-alpha), interleukin-1 beta dosage and bacteriology of pathogenic bacteria associated to CF in children and adolescents with CF.
Intervention code [1] 269498 0
Not applicable
Comparator / control treatment
Active control: Control Group formed by normal-weight subjects without Cystic Fibrosis.
Control group
Active

Outcomes
Primary outcome [1] 279736 0
Assessment of swallowing in children and adolescents with and without cystic fibrosis.
Tools: Swallowing was assessed by a phonoaudiologist. Cervical auscultation was performed with a Littmann, Classic II stethoscope (3M do Brasil, Sumar-SP/Brazil) according to Borr et al. (2007) while oxygen saturation was measured using a Nonnim, pulse oximeter (Plymouth-MN/USA). Following a scale of gravity, swallowing was assessed with solid, pureed and liquid foods, checking for the presence of cough, wet voice (a change in the vocal quality due to food/saliva residues in the vocal cords), integrity of the mechanism of protection of the lower airway (cervical auscultation), oral control of the food bolus (manipulation and transport to the oropharyngeal region), sensation of food being stuck in the throat (stasis of food in the pharynx), multiple swallows and compensatory movements with the head. The diagnosis of swallowing was classified as: normal swallowing, no change with any of the food consistencies and on all of the assessed items; functional swallowing, swallowing is altered, although with no risk of aspiration/laryngeal penetration; light dysphagia, altered swallowing is present with risk of aspiration of liquids, but with the cough reflex present, laryngeal penetration of one or more food consistencies, and potential need for food restriction by oral route; light-moderate dysphagia, risk of aspiration/penetration of food without cough reflex, requirement for compensatory strategies to enable effective swallowing, with restriction or change in one or more food consistencies; moderate dysphagia, significant risk of aspiration, requirement for supervision or feeding strategies and supplementation by enteral route, restriction of two or more food consistencies by oral route; moderate-serious dysphagia, tolerates only one food consistency and under supervision, or with compensation strategies for swallowing, aspirates without a cough reflex, weak voluntary cough, requires use of food supplementation by enteral route, patient with compromised lung function, should not be fed by oral route; serious dysphagia, no possibility of feeding by oral route with any food consistency, chokes, inability to initiate swallowing, nothing transported by oral route.
Timepoint [1] 279736 0
Experiment and control groups were evaluated only once at the end of study.
Primary outcome [2] 279737 0
Evaluate levels of markers involved in oxidative stress and inflammatory process in children and adolescents with and without cystic fibrosis.
Tools: Oxidative stress and inflammation biomarkers. Blood samples were collected in vacuum tubes containing anticoagulant ethylenediaminetetraacetic acid (EDTA) in order to carry out reduced glutathione (GSH), catalase (CAT), glutathione peroxidase (GPx), carbonyl protein (PC), thiobarbituric acid reactive substances (TBARS) and vacuum tubes containing separating gel in order to carry out myeloperoxidase (MPO), C-reactive protein (PCR), nitric oxide metabolites (NOx), adenosine deaminase (ADA), tumor necrosis factor alpha (TNF-alpha), interleukin-1 beta (IL-1beta) dosage. Aliquots of whole blood total were precipitated in trichloroacetic acid (TCA) 12% (1:4, v:v) and stored immediately in liquid nitrogen (-170 degree C), until GSH analysis was carried out. The separation of erythrocytes and plasma, to determine CAT, GPx, PC, TBARS, and the separation of serum, to determine MPO, PCR, NO, ADA, TNF-alpha, IL-1beta, was achieved by centrifugation of the whole blood at 2,500g for 10 minutes, so obtaining the plasmatic, erythrocytic and serum fractions. The samples were stored in a freezer at -80 degree C, with the exception of plasma utilized for TBARS analysis, which was stored in liquid nitrogen (-170 degree C), until testing was carried out. In order to obtain the hemolysates used in CAT and GPx analysis, the erythrocytes were washed twice with saline solution and then centrifuged (5,000 g for 3 min) for posterior lyses as a result of successive freezing and melting. A final centrifugation (5,000 g, for 5 min) supplied the supernatant (hemolysant).
GSH: GSH was determined using the Beutler et al. (1963) method on whole blood. Maximum formation yellow thiolate anion (TNB), is measured at 412nm, in spectrophotometer GBC UV/VIS model 916 (Sydney-New South Wales, Australia), and its concentrations expressed in micro mol/ mL of reduced glutathione.
CAT: CAT was identified in hemolysates utilizing the spectrophotometer method described by Aebi (1984), a process that quantifies the speed of decomposition of hydrogen peroxide in 240 nm, by the enzyme present in the sample. The value of the constant of the activity speed of the enzyme (k) was calculated in the initial seconds, and the values expressed in mmol H2O2 / min/ mL.
GPx: The GPx dosage was measured at 340 nm per spectrophotometry by the glutathione NADPH/ reduced glutathione system by dismutation of tert-butyl hydroperoxide, and the values expressed in micro mol/ min/ mL.
Lipid peroxidation biomarker: Substances which reacted with thiobarbituric acid (TBARS) were measured in the plasma of the individuals. The test was based on the work described by Ohkawa, Oshishi and Yagi and Bird and Draper (1984). The plasma was precipitated by the addition of trichloroacetic acid (TCA) 12%, incubated for 60 minutes at 100 degree C in the presence of 0.9 mL of buffer Tris-HCL 60 mM, pH 7.4 (0.1 mM DPTA) and 1 mL of thiobarbituric acid (TBA) 0.73%. Following incubation, the material was cooled for 30 minutes at 5degree C, and then centrifuged. A reading was taken using the spectrophotometer at 535 nm, and the values expressed in nmol/ mL.
Protein Oxidation Biomarker: Protein carbonyl was determined according to the methods of Levine et al. (1990). The final product of the reaction of 2.4 dinitrophenylhydrazine with protein carbonyl, forming hydrazine proteins in 370 nm, was detected using a spectrophotometer GBC UV/VIS model 916 (Sidney-New South Wales, Australia). The results were expressed in nmoles per milligram of protein, using E (equal to) 22 micro mol L-1 cm1
MPO: MPO was measured in serum according to the method developed by Rao et al. (1993), estimated by colorimetric measure to 450 nm, utilizing the ELISA reader (Organon Teknika - Roseland-NJ, USA). The results are expressed in mU/ mL.
NOx: O NOx was obtained in serum by measuring concentrations of nitrite (NO2-) and nitrate (NO3-), utilizing the Griess reaction, according to the methodology described by Green et al. (1982). The reaction was quantified by optical density measure (543 nm) using the ELISA reader (Organon-Teknica, - Roseland-NJ, USA). Results are expressed in micro mol/L.
PCR: PCR was dosed by the nephelometry method using BN II equipment (Dade Behring, Germany, sensitivity of 3mg/ L) in serum. Results are expressed in mg/ L.
TNF-alpha and IL-1 beta: The cytokine levels were measured by enzyme-linked immunosorbent assay (ELISA) according to the manufacturer's instructions. The cytokine levels were estimated by means of colourimetric measurement at 450 nm with na ELISA plate reader (Organon Teknika, Roseland, NJ, USA) by interpolation from a standard curve.
ADA: ADA was measured in serum using the method of Giusti and Galanti (1984), according to the method developed by Rao et al. (1993), estimated by colorimetric measure to 620 nm, utilizing the ELISA reader (Organon Teknika - Roseland-NJ, USA). The results are expressed in U/l.
Timepoint [2] 279737 0
Experiment and control groups were evaluated only once at the end of study.
Primary outcome [3] 279738 0
Evaluate nutritional status in the children and adolescents with and without cystic fibrosis.
Tools: Nutritional Evaluation. Anthropometric evaluation was carried out following World Health Organization (WHO) guidelines, by a trained professional. The weight of children of up to 2 years of age was taken using a pediatric digital scale - Filizola (Santo Andre, Sao Paulo, Brazil) with a maximum capacity of 15 kg, resolution of 0.01 kg and of the older children with a BK 50 F digital scale (Balmak, Santa Barbara d Oeste, Sao Paulo, Brazil), with a maximum capacity of 150 kg and resolution of 0.1 kg. The length of children of up to 2 years was measured with a infant stadiometer graded from 0 to 150 cm, resolution: 1 mm (Sanny, Sao Paulo, Sao Paulo, Brazil) In children older than 2 height was verified with an anthropometer (Alturaexata, Belo Horizonte, Minas Gerais, Brazil), of scale precision 0.1 cm. The protocol involved: patient fasting, empty bladder, without shoes and using light clothes. The body mass index (BMI) was calculated by the formula: BMI= W/(H)2, with W = weight, in kilograms, and H= height, in squared meters high, (kg/m2). The nutritional state was diagnosed by BMI following WHO guidelines (2006, 2007). To measure the circumference and skinfolds a measuring tape with precision of 0.1 centimeter was used, and the Lange skinfold caliper (Beta Tecnology Corporated - Santa Cruz, California, USA), with scale in millimeters (mm) was used to measure skinfold. For the brachial circumference (BC) and the triceps skinfold (TSF) values referenced in Frisancho (1981) were used. The bicipital (BSF), subscapular (SESF) and suprailiac (SISF) skinfolds were measured by the previous body fat percentage figure. The values for fat mass and lean mass were taken in kilograms. The quantity of lean mass (kg) was compared with data taken in the study by Weinsier et al. (1992).
Timepoint [3] 279738 0
Experiment and control groups were evaluated only once at the end of study.
Secondary outcome [1] 294337 0
Assessment of disease severity by Shwachman-Kulckzyck score in the children and adolescents with cystic fibrosis
Tools: Shwachman-Kulckzyck score. The prognosis of the disease was evaluated by the Shwachman-Kulckzyck score (1958). This score, utilized to classify the degree of seriousness of the illness, is based around general activities as well as a clinical exam, nutritional state and radiological findings. Each item carries the same weighting, twenty five points, and the total of one hundred points represents a perfect score. The patients condition is considered excellent with a score of above 86, good when scoring between 71 and 85, average between 56 and 70, moderate between 41 and 55, and serious minor 40. The age at which the disease was diagnosed was also considered.
Timepoint [1] 294337 0
Experiment group was evaluated only once at the end of study.
Secondary outcome [2] 294338 0
Evaluate the pulmonary function in the children and adolescents with and without cystic fibrosis.
Tools: Pulmonary function evaluation. Pulmonary function was evaluated with a spirometro from the Puritan-Bennett Corporation, Renaissance Spirometry System model (Wilnington-NC, USA), in accordance with the recommendations of the American Thoracic Society. Respiratory obstruction was evaluated with a Forced Expiratory Volume (FEV1).
Timepoint [2] 294338 0
Experiment and control groups were evaluated only once at the end of study.
Secondary outcome [3] 294339 0
Biochemical assessment for characterization of subjects with and without cystic fibrosis
Tools: Biochemical assessment. Blood samples were collected with the patient 10 hours after fasting in the cubital vein in appropriate tubes. The laboratory analyses were performed in serum (with the exception of the hemogram). To obtain serum samples were incubated 10 minutes in a water bath at 37degree C and then centrifuged at 3.000 revolutions per minute for 10 minutes.
Total protein: total protein in serum was analyzed by the Biuret method, with reference values from 6.0 to 8.0 g/dL (GORNALL; BARDAWILL; DAVID, 1949).
Albumin: albumin was determined by bromocresol green, using the Diagnostic Labtest (Lagoa Santa, Minas Gerais, Brazil), by colorimetry, and the reference value from 3.5 to 5.5 g/dL (ASHWOOD; BURTIS, 1996).
Creatinine: creatinine was determined using the automatic method in the kinetic apparatus Abbott Alcyon 300. The normal range of creatinine is 0.4 to 1.3 mg/dL (BURTIS; ASHWOOD, 2001).
Hemogram: hemogram in whole blood was analyzed by semi-automated method. All analyzes were performed with the equipment Cobas Mira (Roche, Rio de Janeiro, Brazil). The reference values for the red blood cells (cells/mm) is 4.2 to 5.6 (first to18 years); for hemoglobin (g/dL) is 12.5 to 16.1 (six months to18 years); for hematocrit (%) is 36 to 47 (six months to 18 years); for leukocytes (p/mm3) is 4.000 to 10.000 (six months to18 years); for segmented neutrophils (p/mm3) is 1.000-6.000 (first to two years), from 1.200 to 6.000 (two to nine years) and from 1.300 to 6.000 (nine to 17 years); for lymphocytes (p/mm3) is 1. 800 to 9000 (first to two years), from 1.000 to 5.500 (two to nine years), from 1.300 to 3.500 (nine to 17 years).
Ferritin: serum ferritin was measured by ELISA, with reference value from 7 to 140 ng/ml for people six months to 15 years, and for those with 16 years of age is the benchmark 20-250 ng/dL (CLOTTEN, 1977).
Fasting glucose: The fasting plasma glucose was determined from hemolysate of the serum by enzymatic colorimetric method (glucose oxidase / hexokinase) (Lukens, 1948). Were considered as the upper limit of normal values up to 99 mg/dL, and inappropriate values between 100 and 125 mg/dL, suggestive of pre-diabetes. Values of 126 mg/dL or more have been redone since it confirms the diagnosis of diabetes (AMERICAN DIABETES ASSOCIATION, 2008).
Timepoint [3] 294339 0
Experiment and control groups were evaluated only once at the end of study.
Secondary outcome [4] 294340 0
Evaluation of fecal fat loss in the children and adolescents with cystic fibrosis.
Tools: Test of Steatocrit and Sudam III assess the loss of fecal fat. The test was carried out by Sudam III method, with reference to negative (SILVEIRA JUNIOR, 1988). The steatocrit was performed by analysis of feces by centrifugation, the method Phuapradit et al. (1981), the reference value being less than 4% (MELO; SILVEIRA, 1995; VALLADA, 1998).
Timepoint [4] 294340 0
Experiment group was evaluated only once at the end of study.
Secondary outcome [5] 294494 0
Biological analysis for characterization of subjects with and without cystic fibrosis
Tools: bacteriological determination. The expectorated sputum samples were obtained in the morning, the patient had been oriented to oral hygiene with water. The sample was collected with the aid of a sterile swab, inserted into the oropharyngeal cavity, directly into a sterile wide-mouth jar, after a deep cough effort. The material was processed immediately after collection, the second methodology Gilligan, Kiska and Appleman (2006). The evaluation was performed by microscopic examination of Gram, whose homogenized formed from 0.5 ml of purulent sputum portion added to 1 ml of sterile saline were inoculated on a plate containing sheep blood agar, chocolate agar plate supplemented with 0.1% yeast extract (Oxoid, Sao Paulo, Brazil) and 20 mg/ml nicotinamide adenine dinucleotide (Sigma-Aldrich (Registered Trademark), Sao Paulo, Brazil), another plate containing the agar and eosin methylene blue latter containing a selective medium for "B. cepacia" (MCPHERSON, PINCUS, 2006). One of the plates of sheep blood agar and chocolate agar incubated in anaerobic environment (GasPak system, Becton Dickinson, Maryland, USA) to prevent possible growth of strict aerobic bacteria. The remaining plates were incubated aerobically at 35 degrees C, examined after 48 hours, kept at room temperature, and re-examined after another 48 hours. From these samples it was possible to establish a score for infection as follows: (0) score for pathogens zero indicating the absence of infection (1) counting mixed oral flora or pathogens isolated colonies on a scale of less than 10 (elevated to two) colony-forming units (CFU)/mL or (2) greater than equal 10 (elevated to five) CFU/mL of a pathogen, characterized the presence of infection in cystic fibrosis.
Timepoint [5] 294494 0
Experiment and control groups were evaluated only once at the end of study.
Secondary outcome [6] 294495 0
Evaluate the salivary parameters and gastro-oesophageal reflux in the children and adolescents with and without cystic fibrosis.
Tools: A DentoBuff INODON (Registered Trademark) kit (Porto Alegre-RS/Brazil) was used to determine the salivary flow and the buffering capacity. The patient chewed a piece of unflavoured paraffin gum for five minutes, collecting the saliva in a graduated cup. Salivary flow in mL/minute was classified according to the manufacturers guidelines as normal greater or equal to 1, decreased greater or equal to 0.7 and less than 1 and low less than 0.7. The buffering capacity was determined in 1.5 mL of saliva in a tube containing acid solution and 4 drops of indicator. It was classified by comparing the colour obtained to a colour scale provided by the manufacturer: low pH less than 4.5, moderate pH between 4.5 and 5.5, and normal when the pH greater than 5.5. Gastro-oesophageal reflux was assessed by oesophageal pH measurement, using the SMP 2128 apparatus from Esograph da Sigmas Instrumentos (Registered Trademark) (Belo Horizonte, MG, Brazil).
Timepoint [6] 294495 0
Experiment and control groups were evaluated only once at the end of study.

Eligibility
Key inclusion criteria
Experimental group: children and adolescents diagnosed with cystic fibrosis with impairment classified as moderate score of Schwachman-Kulczicki. Clinically stable for at least thirty days prior to data collection.
Control group: children and adolescents without cystic fibrosis and without inflammatory symptoms, normal for weight, and paired in age and sex with the cystic fibrosis group.
Minimum age
1 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Experimental group: patients on antibiotics during or even a month before the day of collection and those in period of pulmonary exacerbation. Individuals undergoing mechanical ventilation, intubated-tracheotomised (up to 3 months before or at the time of assessment), undergoing nutritional-enteral therapy, or suffering from cerebral palsy, autism, encephalopathy, Down’s syndrome and other conditions that would compromise swallowing, in a terminal stage. Individual suffering from inflammatory (asthma, intestinal inflammatory illness, rheumatic illness), neurological or degenerative illnesses, renal insufficiency and/or diabetes mellitus, or using antibiotics and/or hormones or non-hormonal anti-inflammatory drugs, up to 6 months before the study.
Control group: Individuals suffering from inflammatory (asthma, intestinal inflammatory illness, rheumatic illness), neurological or degenerative illnesses, renal insufficiency and/or diabetes mellitus, or using antibiotics and/or hormones or non-hormonal anti-inflammatory drugs, up to 6 months before the study. Individuals with symptoms of gastroesophageal reflux (heartburn, regurgitation of food, frequent cough).

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/04/2009
Actual
17/04/2009
Date of last participant enrolment
Anticipated
27/08/2011
Actual
27/08/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
86
Accrual to date
Final
Recruitment outside Australia
Country [1] 3901 0
Brazil
State/province [1] 3901 0
Santa Catarina

Funding & Sponsors
Funding source category [1] 269981 0
Government body
Name [1] 269981 0
Conselho Nacional de Desenvolvimento Cientifico e Tecnologico (CNPq) by Grant and Scholarship of Productivity in Research.
Country [1] 269981 0
Brazil
Funding source category [2] 269982 0
Government body
Name [2] 269982 0
Fundacao de Amparo a Pesquisa e Inovacao do Estado de Santa Catarina - FAPESC
Country [2] 269982 0
Brazil
Primary sponsor type
Individual
Name
Emilia Addison Machado Moreira
Address
Universidade Federal de Santa Catarina (UFSC), Centro de Ciencia da Saude, Departamento de Nutricao - Campus Reitor Joao David Ferreira Lima, Trindade, s/n, Florianopolis, Santa Catarina, ZIP: 88.040-970.
Country
Brazil
Secondary sponsor category [1] 268972 0
Individual
Name [1] 268972 0
Danilo Wilhelm Filho
Address [1] 268972 0
Universidade Federal de Santa Catarina (UFSC), Campus Reitor Joao David Ferreira Lima, Trindade, s/n, Florianopolis, Santa Catarina, ZIP: 88.040-970.
Country [1] 268972 0
Brazil
Other collaborator category [1] 252282 0
Individual
Name [1] 252282 0
Tania Silvia Frode
Address [1] 252282 0
Universidade Federal de Santa Catarina (UFSC) - Campus Reitor Joao David Ferreira Lima, Trindade, s/n, Florianopolis, Santa Catarina, ZIP: 88.040-970.
Country [1] 252282 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271945 0
Ethics Committe for Researchs with Humans of Chidren's Hospital Gusmao of Joana
Ethics committee address [1] 271945 0
Ethics committee country [1] 271945 0
Brazil
Date submitted for ethics approval [1] 271945 0
19/08/2008
Approval date [1] 271945 0
17/02/2009
Ethics approval number [1] 271945 0
048/2008

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33237 0
Dr Emilia Addison Machado Moreira
Address 33237 0
Universidade Federal de Santa Catarina (UFSC), Centro de Ciencia da Saude, Departamento de Nutricao, Campus Reitor Joao David Ferreira Lima, Trindade, s/n, Florianopolis, Santa Catarina, ZIP: 88040-970.
Country 33237 0
Brazil
Phone 33237 0
+55 (48) 3721-9784
Fax 33237 0
+55 (48) 3721-9542
Email 33237 0
[email protected]
Contact person for public queries
Name 16484 0
Emilia Addison Machado Moreira
Address 16484 0
Universidade Federal de Santa Catarina (UFSC), Centro de Ciencia da Saude, Departamento de Nutricao, Campus Reitor Joao David Ferreira Lima, Trindade, s/n, Florianopolis, Santa Catarina, ZIP: 88040-970.
Country 16484 0
Brazil
Phone 16484 0
+55 (48) 3721-9784
Fax 16484 0
+55 (48) 3721-9542
Email 16484 0
[email protected]
Contact person for scientific queries
Name 7412 0
Emilia Addison Machado Moreira
Address 7412 0
Universidade Federal de Santa Catarina (UFSC), Centro de Ciencia da Saude, Departamento de Nutricao, Campus Reitor Joao David Ferreira Lima, Trindade, s/n, Florianopolis, Santa Catarina, ZIP: 88040-970.
Country 7412 0
Brazil
Phone 7412 0
+55 (48) 3721-9784
Fax 7412 0
+55 (48) 3721-9542
Email 7412 0
[email protected]

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SourceTitleYear of PublicationDOI
EmbaseSystemic oxidative stress in children with cystic fibrosis with bacterial infection including Pseudomonas Aeruginosa.2022https://dx.doi.org/10.1111/crj.13513
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