Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000162910
Ethics application status
Approved
Date submitted
9/02/2011
Date registered
10/02/2011
Date last updated
27/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Vitamin C uptake from kiwifruit compared with a vitamin C supplement
Scientific title
Vitamin C bioavailability from kiwifruit compared with a vitamin C supplement - a randomised parallel study in men
Secondary ID [1] 253573 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin C status 261141 0
Condition category
Condition code
Public Health 259296 259296 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 - baseline period (4 weeks) to monitor dietary intake of vitamin C; intervention period (6 weeks) - gold kiwifruit (half/day); washout period (4 weeks) to monitor return of plasma vitamin C to baseline levels. Arm 2 - baseline period (4 weeks) to monitor dietary intake of vitamin C; intervention period (6 weeks) - chewable vitamin C tablet (45mg/day); washout period (4 weeks) to monitor return of plasma vitamin C to baseline levels. Arm 3 - baseline period (4 weeks) to monitor dietary intake of vitamin C; intervention period (6 weeks) - gold kiwifruit (two/day); washout period (4 weeks) to monitor return of plasma vitamin C to baseline levels.
Intervention code [1] 258002 0
Lifestyle
Intervention code [2] 258010 0
Treatment: Other
Comparator / control treatment
Arm 2 - vitamin C supplement
Control group
Active

Outcomes
Primary outcome [1] 262096 0
Measurement of vitamin C status of blood plasma by HPLC
Timepoint [1] 262096 0
Weekly for 14-16 weeks
Secondary outcome [1] 273145 0
Measurement of vitamin C status of white blood cells by HPLC
Timepoint [1] 273145 0
Before intervention and after intervention (6-8 weeks)
Secondary outcome [2] 273146 0
Measurement of vitamin C status of urine by HPLC
Timepoint [2] 273146 0
Before intervention and after intervention (6-8 weeks)
Secondary outcome [3] 273147 0
Measurement of vitamin C status of seminal fluid by HPLC
Timepoint [3] 273147 0
Before intervention and after intervention (6-8 weeks)
Secondary outcome [4] 273148 0
Measurement of vitamin C status of muscle biopsies by HPLC
Timepoint [4] 273148 0
Before intervention and after intervention (6-8 weeks)
Secondary outcome [5] 273149 0
Assessment of Profile of Mood States questionnaire
Timepoint [5] 273149 0
Before intervention and after intervention (6-8 weeks)

Eligibility
Key inclusion criteria
Male aged 18-30 years
Non-smoker
Low/below average plasma vitamin C levels (<40 uM)
Residing in Christchurch for the duration of the study
Minimum age
18 Years
Maximum age
30 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Recent smoker (within previous year)
Allergy/intolerance to kiwifruit
Taking vitamin C containing supplements (within past three months)
Excessive alcohol consumption (>21 standard drinks/week)
High fruit and vegetable consumption (>5 servings/day)
Diabetes mellitus
Bleeding disorders
Obese (>35 kg/m2)
Fear of needles

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be enrolled following screening for low vitamin C status
Allocation to intervention will be by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised via coin toss
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/06/2011
Actual
15/06/2011
Date of last participant enrolment
Anticipated
Actual
26/07/2011
Date of last data collection
Anticipated
Actual
13/12/2011
Sample size
Target
50
Accrual to date
Final
54
Recruitment outside Australia
Country [1] 3174 0
New Zealand
State/province [1] 3174 0
Canterbury

Funding & Sponsors
Funding source category [1] 258463 0
Commercial sector/Industry
Name [1] 258463 0
Zespri International Ltd
Country [1] 258463 0
New Zealand
Primary sponsor type
Individual
Name
Margreet Vissers
Address
University of Otago, Chirsthurch
2 Riccarton Ave
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 257605 0
Individual
Name [1] 257605 0
Anitra Carr
Address [1] 257605 0
University of Otago, Chirsthurch
2 Riccarton Ave
Christchurch 8140
Country [1] 257605 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260443 0
Upper South Regional Ethics Committee
Ethics committee address [1] 260443 0
Ethics committee country [1] 260443 0
New Zealand
Date submitted for ethics approval [1] 260443 0
07/02/2011
Approval date [1] 260443 0
Ethics approval number [1] 260443 0

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

Contacts
Principal investigator
Name 32192 0
Prof Margreet Vissers
Address 32192 0
University of Otago, Christchurch 2 Riccarton Ave Christchurch 8140
Country 32192 0
New Zealand
Phone 32192 0
64 3 364 1524
Fax 32192 0
Email 32192 0
[email protected]
Contact person for public queries
Name 15439 0
Anitra Carr
Address 15439 0
University of Otago, Christchurch
2 Riccarton Ave
Christchurch 8140
Country 15439 0
New Zealand
Phone 15439 0
64 3 378 6498
Fax 15439 0
Email 15439 0
[email protected]
Contact person for scientific queries
Name 6367 0
Margreet Vissers
Address 6367 0
University of Otago, Christchurch
2 Riccarton Ave
Christchurch 8140
Country 6367 0
New Zealand
Phone 6367 0
64 3 364 1524
Fax 6367 0
Email 6367 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIMood improvement in young adult males following supplementation with gold kiwifruit, a high-vitamin C food2013https://doi.org/10.1017/jns.2013.12
EmbaseMarginal ascorbate status (Hypovitaminosis C) results in an attenuated response to vitamin C supplementation.2016https://dx.doi.org/10.3390/nu8060341
N.B. These documents automatically identified may not have been verified by the study sponsor.