Vitamin D Supplementation in Physical Performance | NCT03325686

Studies
Vitamin D Supplementation in Physical Performance

NCT03325686

Sponsor

National Nutrition and Food Technology Institute

Status

Completed

Last Update Posted

Oct 30, 2017Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Healthy
Athletes

Interventions

vitamin D supplement
Placebo

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2017Actual

Primary Completion Date

Sep 1, 2017Actual

Completion Date

Sep 30, 2017Actual

First Submitted Date

Oct 20, 2017

First Submission Date that Met QC Criteria

Oct 27, 2017

First Posted Date

Oct 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2017

Last Update Posted Date

Oct 30, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tirang R. Neyestani, Ph.D., Professor, National Nutrition and Food Technology InstitutePrincipal Investigator

Lead Sponsor

National Nutrition and Food Technology InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vitamin D supplement	Experimental	D	Dietary Supplement: vitamin D supplement
control	Placebo Comparator	P	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vitamin D supplement	Dietary Supplement	D; received 50,000 IU of vitamin D supplement weekly	vitamin D supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes from baseline serum 25-hydroxy vitamin D at eight weeks	nmol/L	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes from baseline Truncal Fat at eight weeks	percent	8 weeks
Changes from baseline visceral fat at eight weeks	percent	8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy
professional athletes

Exclusion Criteria:

receiving vitamin D supplement in past 3 months

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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 Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Nutrition and Food Technology Research Institute		Tehrān	Tehran Province		Iran

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C007792	Fumigant 93

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided