HealthyNCT03325686
Vitamin D Supplementation in Physical Performance
A study testing vitamin D supplement in people with Healthy and Athletes, run by National Nutrition and Food Technology Institute at 1 site in Iran.
Trial summary
This study was performed to evaluate the efficacy of weekly vitamin D supplementation on athletic performance in Iranian athletes Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- What is being tested?
- vitamin D supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIran
- Study dates
- 1 Mar 2017to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- professional athletes
Who cannot join
- receiving vitamin D supplement in past 3 months
Trial locations and contacts
1 site in 1 country.
Iran1 site
National Nutrition and Food Technology Research Institute
Tehrān, Tehran Province
About this study
Official title: 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
Read the 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.
- Being tested
- vitamin D supplement, Placebo
- Keywords
- vitamin D, atletes, physical performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D supplementDietary supplement
Also called D
D; received 50,000 IU of vitamin D supplement weekly
PlaceboOther
Also called P
placebo
| Study group | Role | What they receive |
|---|---|---|
| vitamin D supplement | Experimental | D Receives: Dietary Supplement: vitamin D supplement |
| control | Placebo comparator | P Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline serum 25-hydroxy vitamin D at eight weeks
nmol/L
Measured: 8 weeks
Secondary outcomes (7)
Changes from baseline Truncal Fat at eight weeks
percent
Measured: 8 weeks
Changes from baseline visceral fat at eight weeks
percent
Measured: 8 weeks
Changes from Strength leg press at 8 weeks
percent
Measured: 8 weeks
Changes from Ergojump at 8 weeks
percent
Measured: 8 weeks
Changes from baseline Vertical jump at 8 weeks
percent
Measured: 8 weeks
Change from baseline Agility at 8 weeks
percent
Measured: 8 weeks
changes from Speed at 8 weeks
percent
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start1 Mar 2017
- Primary completion1 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tirang R. Neyestani, Ph.D., National Nutrition and Food Technology Institute
- Investigators
- Tirang R. Neyestani, PhD, Study chair, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325686
- Sponsor's protocol ID
- 054-575
- Status last verified
- Oct 2017
- First submitted
- 20 Oct 2017
- Last updated
- 30 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Vitamin D Supplementation in Physical Performance of Iranian Elite Athletes
- ClinicalTrials.gov ID
- NCT03325686
- Acronym / sponsor ID
- 054-575
- Keywords
- vitamin D, atletes, physical performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was performed to evaluate the efficacy of weekly vitamin D supplementation on athletic performance in Iranian athletes
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D supplement | Experimental | Dietary Supplement: vitamin D supplementD |
| control | Placebo comparator | Other: PlaceboP |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy
- professional athletes
Key exclusion criteria (1 listed)
- receiving vitamin D supplement in past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin D supplementAlso: DD; received 50,000 IU of vitamin D supplement weekly | Dietary supplement | vitamin D supplement |
| PlaceboAlso: Pplacebo | Other | control |
Primary outcome
Changes from baseline serum 25-hydroxy vitamin D at eight weeks
Time frame: 8 weeks
nmol/L
7 secondary outcomes
Changes from baseline Truncal Fat at eight weeks
Time frame: 8 weeks
Changes from baseline visceral fat at eight weeks
Time frame: 8 weeks
Changes from Strength leg press at 8 weeks
Time frame: 8 weeks
Changes from Ergojump at 8 weeks
Time frame: 8 weeks
Changes from baseline Vertical jump at 8 weeks
Time frame: 8 weeks
Change from baseline Agility at 8 weeks
Time frame: 8 weeks
changes from Speed at 8 weeks
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
Recruiting
Effects of a Hemp Seed-based Product on Appetite and Health Parameters
Healthy
RecruitingPhase 1
A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH
Metabolic Dysfunction-Associated Steatohepatitis
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
Not yet recruiting
Stearic Acid and Endothelial Function
Healthy Middle-aged Subjects, Obesity & Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tirang R. Neyestani, PhD study chair
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin D supplement in people with Healthy and Athletes, run by National Nutrition and Food Technology Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline serum 25-hydroxy vitamin D at eight weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017; AzTrials last refreshed its copy on 5 Nov 2026.