NCT05489666

Brief Summary

The majority of vitamin D research has been done in non-athletic populations, particularly older populations, to analyze muscle weakness, pain, balance, and fractures. It has been reported that over a billion people worldwide are vitamin D deficient, including 36-70% of the young adult population. Previous literature also suggests that, even among healthy athletes, over 50% of subjects sampled had inadequate or insufficient vitamin D levels. Vitamin D deficiency can occur in young women, including pregnant women, and the risk of deficiency is even higher with advancing age in a woman's lifecycle. It is known that preserving skeletal muscle (SM) function is critical for women of all ages to prevent sarcopenia. Two factors in preserving SM are protein intake and resistance training. Relatively unknown are the actions of Vitamin D on SM function. Vitamin D deficiency can have a negative effect on SM function . However, additional research is needed to investigate the increase in SM strength when the serum concentration of vitamin D is improved. It is possible that an athlete may require an increased intake of vitamin D to assure adequate availability and storage for optimal performance; however, is known that food sources of vitamin D are limited in sufficient quantity to meet these requirements. Athletes who are insufficient will require a supplement of vitamin D3 for up to 5000 IU/day for at least eight weeks, to potentially reach optimal levels, then 1000-2000 IU/day for maintenance.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

August 3, 2022

Last Update Submit

August 8, 2022

Conditions

Keywords

NutritionSupplementSupplementationVitamin DStrength TrainingResistance TrainingWomenFemaleAthlete

Outcome Measures

Primary Outcomes (1)

  • Biodex Strength performance change

    Taking a daily supplement of 5,000 IU of vitamin D3 may change strength outcomes measured in newton meters (Nm).

    8 weeks

Secondary Outcomes (1)

  • Serum 25(OH)D status

    8 weeks

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

Participants in this group will be administered an oral Vitamin D3 supplement; 5,000 IU/ day. The participants will take the supplement themselves, orally, once per day, for 8 weeks.

Dietary Supplement: Nature Made Vitamin D3 5,000 IU, 125mcg

Control Group

PLACEBO COMPARATOR

Participants in this group will be administered an oral, soft-gel, lookalike placebo. The participants will take the supplement themselves, orally, once per day, for 8 weeks.

Dietary Supplement: Placebo

Interventions

Taking a 5,000 IU oral supplement of Vitamin D3, daily, for 8 weeks, may improve strength performance in women who have and are continuing a resistance trained workout regimen. After blood vitamin D levels have been raised to an optimal range, a lower dosage may be assigned as needed from 5,000 IU per day to 1,000-2,000 IU per day.

Also known as: Spring Valley, Life Extensions, GNC, Nature's Bounty, CVSHealth, Swanson
Treatment Group
PlaceboDIETARY_SUPPLEMENT

Resistance trained women may not improve their strength performance with low levels of vitamin D in the blood.

Control Group

Eligibility Criteria

Age19 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participant will need to answer "yes" to the following items:
  • female
  • not pregnant
  • between the ages of 19-55 years old
  • a non-smoker
  • currently resistance training (i.e., lifting weights) for more than 2 days/week for a minimum of \> 24 months
  • free of any known overt cardiovascular or metabolic disease
  • not an active user of tanning beds
  • not consuming now or haven't consumed within the last 6 months, a vitamin D or multivitamin supplement or a form of a supplement with vitamin D added
  • not consuming now or haven't consumed within the last 2 months, agents that affect hormones (testosterone boosters, growth hormone boosters, etc.) (does not include birth control/oral contraceptives)
  • not allergic to rubbing alcohol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Abrams GD, Feldman D, Safran MR. Effects of Vitamin D on Skeletal Muscle and Athletic Performance. J Am Acad Orthop Surg. 2018 Apr 15;26(8):278-285. doi: 10.5435/JAAOS-D-16-00464.

  • Bartoszewska M, Kamboj M, Patel DR. Vitamin D, muscle function, and exercise performance. Pediatr Clin North Am. 2010 Jun;57(3):849-61. doi: 10.1016/j.pcl.2010.03.008.

  • Chiang CM, Ismaeel A, Griffis RB, Weems S. Effects of Vitamin D Supplementation on Muscle Strength in Athletes: A Systematic Review. J Strength Cond Res. 2017 Feb;31(2):566-574. doi: 10.1519/JSC.0000000000001518.

  • Dahlquist DT, Dieter BP, Koehle MS. Plausible ergogenic effects of vitamin D on athletic performance and recovery. J Int Soc Sports Nutr. 2015 Aug 19;12:33. doi: 10.1186/s12970-015-0093-8. eCollection 2015.

  • Han Q, Li X, Tan Q, Shao J, Yi M. Effects of vitamin D3 supplementation on serum 25(OH)D concentration and strength in athletes: a systematic review and meta-analysis of randomized controlled trials. J Int Soc Sports Nutr. 2019 Nov 26;16(1):55. doi: 10.1186/s12970-019-0323-6.

  • Knechtle B, Nikolaidis PT. Vitamin D and Sport Performance. Nutrients. 2020 Mar 21;12(3):841. doi: 10.3390/nu12030841.

  • Ksiazek A, Zagrodna A, Slowinska-Lisowska M. Vitamin D, Skeletal Muscle Function and Athletic Performance in Athletes-A Narrative Review. Nutrients. 2019 Aug 4;11(8):1800. doi: 10.3390/nu11081800.

  • Ogan D, Pritchett K. Vitamin D and the athlete: risks, recommendations, and benefits. Nutrients. 2013 May 28;5(6):1856-68. doi: 10.3390/nu5061856.

  • Stockton KA, Mengersen K, Paratz JD, Kandiah D, Bennell KL. Effect of vitamin D supplementation on muscle strength: a systematic review and meta-analysis. Osteoporos Int. 2011 Mar;22(3):859-71. doi: 10.1007/s00198-010-1407-y. Epub 2010 Oct 6.

  • Tomlinson PB, Joseph C, Angioi M. Effects of vitamin D supplementation on upper and lower body muscle strength levels in healthy individuals. A systematic review with meta-analysis. J Sci Med Sport. 2015 Sep;18(5):575-80. doi: 10.1016/j.jsams.2014.07.022. Epub 2014 Aug 11.

  • Wicinski M, Adamkiewicz D, Adamkiewicz M, Sniegocki M, Podhorecka M, Szychta P, Malinowski B. Impact of Vitamin D on Physical Efficiency and Exercise Performance-A Review. Nutrients. 2019 Nov 19;11(11):2826. doi: 10.3390/nu11112826.

  • de la Puente Yague M, Collado Yurrita L, Ciudad Cabanas MJ, Cuadrado Cenzual MA. Role of Vitamin D in Athletes and Their Performance: Current Concepts and New Trends. Nutrients. 2020 Feb 23;12(2):579. doi: 10.3390/nu12020579.

Study Officials

  • Donna O Burnett, PhD

    Auburn University

    STUDY CHAIR

Central Study Contacts

Nilophar L Zandieh, MS

CONTACT

Donna O Burnett, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-blind masking; neither the investigator nor the participants will know, the assigned intervention placement.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: A two-arm parallel assignment; one group receives the treatment (vitamin D3 supplement 5,000IU/day) and one group receives the placebo (control).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

August 3, 2022

First Posted

August 5, 2022

Study Start

September 1, 2022

Primary Completion

November 30, 2022

Study Completion

February 1, 2023

Last Updated

August 10, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share