- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03325686
Vitamin D Supplementation in Physical Performance
October 27, 2017 updated by: Tirang R. Neyestani, Ph.D., National Nutrition and Food Technology Institute
Efficacy of Vitamin D Supplementation in Physical Performance of Iranian Elite Athletes
This study was performed to evaluate the efficacy of weekly vitamin D supplementation on athletic performance in Iranian athletes
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Seventy subjects were enrolled in the study.
The athletes were randomly divided into two groups: vitamin D supplement (D; received 50,000 IU of vitamin D supplement weekly) and control (P, received a placebo weekly).
Duration of the study was eight weeks.
Anthropometric, dietary, athletic performance and biochemical evaluations were performed for all subjects in the beginning and in the end of the intervention period.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tehran
-
Tehrān, Tehran, Iran, Islamic Republic of
- National Nutrition and Food Technology Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy
- professional athletes
Exclusion Criteria:
- receiving vitamin D supplement in past 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: vitamin D supplement
D
|
D; received 50,000 IU of vitamin D supplement weekly
Other Names:
|
Placebo Comparator: control
P
|
placebo
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline serum 25-hydroxy vitamin D at eight weeks
Time Frame: 8 weeks
|
nmol/L
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline Truncal Fat at eight weeks
Time Frame: 8 weeks
|
percent
|
8 weeks
|
Changes from baseline visceral fat at eight weeks
Time Frame: 8 weeks
|
percent
|
8 weeks
|
Changes from Strength leg press at 8 weeks
Time Frame: 8 weeks
|
percent
|
8 weeks
|
Changes from Ergojump at 8 weeks
Time Frame: 8 weeks
|
percent
|
8 weeks
|
Changes from baseline Vertical jump at 8 weeks
Time Frame: 8 weeks
|
percent
|
8 weeks
|
Change from baseline Agility at 8 weeks
Time Frame: 8 weeks
|
percent
|
8 weeks
|
changes from Speed at 8 weeks
Time Frame: 8 weeks
|
percent
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Tirang R. Neyestani, PhD, Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute (NNFTRI) and Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2017
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
September 30, 2017
Study Registration Dates
First Submitted
October 20, 2017
First Submitted That Met QC Criteria
October 27, 2017
First Posted (Actual)
October 30, 2017
Study Record Updates
Last Update Posted (Actual)
October 30, 2017
Last Update Submitted That Met QC Criteria
October 27, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 054-575
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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