Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001057077
Ethics application status
Approved
Date submitted
9/09/2008
Date registered
1/12/2010
Date last updated
1/12/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Rehydration with Intravenous Fluid and Oral Glycerol in Athletes: Effects on Cardiovascular, Hormonal, Thermoregulatory, Metabolic and Performance Variables
Scientific title
In athletes, is intravenous fluid with oral glycerol comparable to either intervention alone or placebo, for rehydration
Secondary ID [1] 253205 0
HMS06/2303/4
Universal Trial Number (UTN)
U1111-1118-3236
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dehydration 3654 0
Condition category
Condition code
Other 3822 3822 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All subjects completed all four experimental trials in a randomised crossover sequence: (1) 100% oral fluid without glycerol (oral); (2) 100% oral fluid with oral glycerol (oral with glycerol); (3) 50% oral fluid, 50% intravenous (IV) fluid (0.9% NaCl), without glycerol (IV); and (4) 50% oral fluid, 50% intravenous fluid (0.9% NaCl) with oral glycerol (IV with oral glycerol). Trials were conducted at least two weeks apart.

In each experimental trial, subjects were initially dehydrated via cycling exercise in the heat (35oC, 70% relative humidity) to -4% bodyweight. The interventions (oral [control trial], oral with glycerol, IV and IV with oral glycerol) were then provided during rehydration over a two hour period. The total volume of rehydration was 150% of the bodyweight lost. In the first hour, subjects were given 100% of the bodyweight lost, with a further 50% provided in the second hour of rehydration.

Glycerol (1.5 g/kg bodyweight) was provided orally in a sports drink (Gatorade) solution during two hours of rehydration (after being dehydrated by -4% bodyweight) in the oral with glycerol and IV with glycerol trials. The overall dose was provided in two fluid boluses containing 1.0 g/kg and 0.5 g/kg during the first and second hours of rehydration, respectively.

Intravenous fluids (0.9% NaCl) were administered in the IV and IV with oral glycerol trials. In these trials, half the rehydration volume was IV fluid and the other half was oral fluid.
Intervention code [1] 3370 0
Treatment: Other
Comparator / control treatment
Water and sports drink (Gatorade) are provided in combination as the control/placebo (oral) rehydration condition.

Subjects were initially dehydrated via cycling exercise in the heat (35oC, 70% relative humidity) to -4% bodyweight. The placebo solutions (water and Gatorade) were then provided during rehydration over a two hour period. The total volume of rehydration was 150% of the bodyweight lost. In the first hour, subjects were given 100% of the bodyweight lost, with a further 50% provided in the second hour of rehydration.

Intravenous fluids were only provided in the IV and IV with oral glycerol trials)
Control group
Placebo

Outcomes
Primary outcome [1] 4719 0
Change in plasma volume (measured using changes to heamoglobin/heamatocrit and Dill and Costal equations) to monitor hydration status.
Timepoint [1] 4719 0
Pre-dehydration, -1% bodyweight, -2% bodyweight, -3% bodyweight, post-dehydration, post-first hour of rehydration, mid-second hour of rehydration, post-second hour of rehydration, mid-equilibration, post-equilibration and following 15 min, 30 min, 10 km, 20 km, 30 km and 40 km of an exercise performance test.
Primary outcome [2] 259750 0
Exercise performance assessed as time to complete a 40 km time trial.
Timepoint [2] 259750 0
Following 10 km, 20 km, 30 km and 40 km of a 40 km time trial.
Secondary outcome [1] 7968 0
Change in aldosterone concentration (measured using a high-performance liquid chromatography-tandem mass spectrometric method) to reflect hydration status.
Timepoint [1] 7968 0
Pre-dehydration, -1% bodyweight, -2% bodyweight, -3% bodyweight, post-dehydration, post-first hour of rehydration, mid-second hour of rehydration, post-second hour of rehydration, mid-equilibration, post-equilibration and following 30 min, 20 km and 40 km of an exercise performance test.
Secondary outcome [2] 268508 0
Change in cortisol concentration (measured using a high-performance liquid chromatography-tandem mass spectrometric method) to reflect stress response.
Timepoint [2] 268508 0
Pre-dehydration, -1% bodyweight, -2% bodyweight, -3% bodyweight, post-dehydration, post-first hour of rehydration, mid-second hour of rehydration, post-second hour of rehydration, mid-equilibration, post-equilibration and following 30 min, 20 km and 40 km of an exercise performance test.
Secondary outcome [3] 268509 0
Plasma osmolality (measured using vapour pressure osmometer)
Timepoint [3] 268509 0
Pre-dehydration, -1% bodyweight, -2% bodyweight, -3% bodyweight, post-dehydration, post-first hour of rehydration, mid-second hour of rehydration, post-second hour of rehydration, mid-equilibration, post-equilibration and following 15 min, 30 min, 10 km, 20 km, 30 km and 40 km of an exercise performance test.

Eligibility
Key inclusion criteria
1) male aged 18 – 40 yrs;
2) experienced cyclist;
3) high endurance training status (V•O2max > 55 mL · kg-1 · min-1); and
4) consistently high training volumes for at least the preceding two months
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) a history of current or previous renal, hepatic, cardiovascular, thermoregulatory or endocrine disorders;
2) contraindications to exercising in the heat;
3) any current or chronic health problems or injuries;
4) the use of any diuretic during the preceding four weeks; and
5) having made a blood donation in the preceding three months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3485 0
4067
Recruitment postcode(s) [2] 3486 0
4068
Recruitment postcode(s) [3] 3487 0
4064
Recruitment postcode(s) [4] 3488 0
4103
Recruitment postcode(s) [5] 3489 0
4121
Recruitment postcode(s) [6] 3490 0
4520
Recruitment postcode(s) [7] 3491 0
4072
Recruitment postcode(s) [8] 3492 0
4113

Funding & Sponsors
Funding source category [1] 3835 0
University
Name [1] 3835 0
University of Queensland
Country [1] 3835 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Human Movement Studies
Blair Dr, St Lucia Campus
Brisbane
QLD 4072
Country
Australia
Secondary sponsor category [1] 3444 0
None
Name [1] 3444 0
Address [1] 3444 0
Country [1] 3444 0
Other collaborator category [1] 251705 0
Government body
Name [1] 251705 0
Queensland Academy of Sport
Address [1] 251705 0
Queensland Sport and Athletics Centre (QSAC)
Kessels Road
Nathan QLD 4111
Country [1] 251705 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5887 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 5887 0
Ethics committee country [1] 5887 0
Australia
Date submitted for ethics approval [1] 5887 0
Approval date [1] 5887 0
23/02/2006
Ethics approval number [1] 5887 0
HMS06/2303/4

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

Contacts
Principal investigator
Name 28909 0
Address 28909 0
Country 28909 0
Phone 28909 0
Fax 28909 0
Email 28909 0
Contact person for public queries
Name 12066 0
Simon van Rosendal
Address 12066 0
School of Human Movement Studies
University of Queensland
Blair Dr, St Lucia Campus
Brisbane
QLD 4072
Country 12066 0
Australia
Phone 12066 0
+61 421856932
Fax 12066 0
Email 12066 0
[email protected]
Contact person for scientific queries
Name 2994 0
Gary Wilson
Address 2994 0
School of Human Movement Studies
University of Queensland
Blair Dr, St Lucia Campus
Brisbane
QLD 4072
Country 2994 0
Australia
Phone 2994 0
+61 7 3365 6445
Fax 2994 0
Email 2994 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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