Clinical trial NCT05489666: Effects of Vitamin D on Skeletal Muscle Strength in Resistance Trained Adult Females
Official title: Effects of Vitamin D on Skeletal Muscle Strength in Resistance Trained Adult Females
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nutrition Status
Nutritional Requirements
Sports Nutritional Sciences
Keywords: Nutrition
Supplement
Supplementation
Vitamin D
Strength Training
Resistance Training
Women
Female
Athlete
Lead sponsor: Auburn University
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-arm parallel assignment; one group receives the treatment (vitamin D3 supplement 5,000IU/day) and one group receives the placebo (control).
Primary purpose: BASIC_SCIENCE

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.

Detailed description: The investigators seek to determine if women with a vitamin D serum concentration lower than 50 nmol/L and who regularly resistance train will improve strength performance outcomes when taking a daily supplement of 5000 IU of vitamin D3 over an 8-week period, as compared to the same demographic of women who do not take a daily supplement of vitamin D3. The participants will receive "Nature's Bounty Vitamin D3, 5,000 IU, soft gels" and the PI will be providing the supplement and the placebo. A pre-intervention data collection and screening (PRE) will be performed involving blood draw, food log, a body composition test (using Dual-energy X-ray absorptiometry \[DEXA\]), and a BioDex testing to determine maximal muscle strength. Following PRE testing, the participants will be divided into one of two groups: 1) taking a vitamin D3 supplement (n=20) or, 2) taking a placebo. The participants will be instructed to continue their resistance training regimen. Training will be logged and turned in to the PI weekly. The participants will perform a post-intervention data collection (POST), which includes the same test from PRE. Variables of interest will include changes in: 1) blood level of vitamin D, 2) muscle and fat mass, and 3) leg strength/power during the BioDex test.

Eligibility criteria: Inclusion criteria will include:

Participant will need to answer "yes" to the following items:

1. female
2. not pregnant
3. between the ages of 19-55 years old
4. a non-smoker
5. currently resistance training (i.e., lifting weights) for more than 2 days/week for a minimum of \> 24 months
6. free of any known overt cardiovascular or metabolic disease
7. not an active user of tanning beds
8. 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
9. 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)
10. not allergic to rubbing alcohol

Exclusion criteria will include:

1) Outside of study inclusion parameters

Primary outcomes:
measure: Biodex Strength performance change
timeFrame: 8 weeks
Secondary outcomes:
measure: Serum 25(OH)D status
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Auburn University
name: Donna O Burnett, PhD
role: STUDY_CHAIR
References:
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