Effects of Vitamin D on Skeletal Muscle Strength in Resistance Trained Adult Females

NCT ID: NCT05489666

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-02-01

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.

Conditions

Nutrition Status; Nutritional Requirements; Sports Nutritional Sciences

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Treatment Group

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.

Group Type: ACTIVE_COMPARATOR

Nature Made Vitamin D3 5,000 IU, 125mcg

Intervention Type: DIETARY_SUPPLEMENT

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.

Control Group

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Nature Made Vitamin D3 5,000 IU, 125mcg

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Spring Valley; Life Extensions; GNC; Nature's Bounty; CVSHealth; Swanson

Eligibility Criteria

Inclusion Criteria

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

1) Outside of study inclusion parameters

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Auburn University

OTHER

Sponsor Role: lead

Responsible Party

Nilophar Zandieh, MS

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donna O Burnett, PhD

Role: STUDY_CHAIR

Auburn University

Central Contacts

Nilophar L Zandieh, MS

Role: CONTACT

nlz0005@auburn.edu

9492447504

Donna O Burnett, PhD

Role: CONTACT

dob0002@auburn.edu

334-844-3429

References

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Other Identifiers

22-306

Identifier Type: -

Identifier Source: org_study_id