Nutrition StatusNCT05489666
Effects of Vitamin D on Skeletal Muscle Strength in Resistance Trained Adult Females
A study testing Nature Made Vitamin D3 5,000 IU, 125mcg in people with Nutrition Status and Nutritional Requirements, run by Auburn University.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nutrition Status, Nutritional Requirements, Sports Nutritional Sciences
- What is being tested?
- Nature Made Vitamin D3 5,000 IU, 125mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Feb 2023
- 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 19 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 1) Outside of study inclusion parameters
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- Nature Made Vitamin D3 5,000 IU, 125mcg, Placebo
- Keywords
- Nutrition, Supplement, Supplementation, Vitamin D, Strength Training, Resistance Training, Women, Female, Athlete
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature Made Vitamin D3 5,000 IU, 125mcgDietary supplement
Also called Spring Valley, Life Extensions, GNC, Nature's Bounty
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.
PlaceboDietary supplement
Resistance trained women may not improve their strength performance with low levels of vitamin D in the blood.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex Strength performance change
Taking a daily supplement of 5,000 IU of vitamin D3 may change strength outcomes measured in newton meters (Nm).
Measured: 8 weeks
Secondary outcomes (1)
Serum 25(OH)D status
Taking a daily supplement of 5,000 IU of vitamin D3 may change blood levels of vitamin D.
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 posted5 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Nutrition StatusStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilophar Zandieh, MS, Auburn University
- Investigators
- Donna O Burnett, PhD, Study chair, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489666
- Sponsor's protocol ID
- 22-306
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29561306Bartoszewska 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.
PubMed 20538161Chiang 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.
PubMed 27379960Dahlquist 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.
PubMed 26288575Han 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.
PubMed 31771586Knechtle B, Nikolaidis PT. Vitamin D and Sport Performance. Nutrients. 2020 Mar 21;12(3):841. doi: 10.3390/nu12030841.
PubMed 32245151Ksiazek 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.
PubMed 31382666Ogan D, Pritchett K. Vitamin D and the athlete: risks, recommendations, and benefits. Nutrients. 2013 May 28;5(6):1856-68. doi: 10.3390/nu5061856.
PubMed 23760056Stockton 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.
PubMed 20924748Tomlinson 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.
PubMed 25156880Wicinski 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.
PubMed 31752277de 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.
PubMed 32102188
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D on Skeletal Muscle Strength in Resistance Trained Adult Females
- ClinicalTrials.gov ID
- NCT05489666
- Acronym / sponsor ID
- 22-306
- Keywords
- Nutrition, Supplement, Supplementation, Vitamin D, Strength Training, Resistance Training, Women, Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 5 Aug 2022 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Dietary Supplement: Nature Made Vitamin D3 5,000 IU, 125mcgParticipants 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. |
| Control Group | Placebo comparator | Dietary Supplement: PlaceboParticipants 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. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (1 listed)
- 1) Outside of study inclusion parameters
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 |
|---|---|---|
| Nature Made Vitamin D3 5,000 IU, 125mcgAlso: Spring Valley, Life Extensions, GNC, Nature's BountyTaking 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. | Dietary supplement | Treatment Group |
| PlaceboResistance trained women may not improve their strength performance with low levels of vitamin D in the blood. | Dietary supplement | Control Group |
Primary outcome
Biodex Strength performance change
Time frame: 8 weeks
Taking a daily supplement of 5,000 IU of vitamin D3 may change strength outcomes measured in newton meters (Nm).
1 secondary outcome
Serum 25(OH)D status
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Results publication: PubMed 29561306Abrams 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.
- Results publication: PubMed 20538161Bartoszewska 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.
- Results publication: PubMed 27379960Chiang 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.
- Results publication: PubMed 26288575Dahlquist 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.
- Results publication: PubMed 31771586Han 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.
- Results publication: PubMed 32245151Knechtle B, Nikolaidis PT. Vitamin D and Sport Performance. Nutrients. 2020 Mar 21;12(3):841. doi: 10.3390/nu12030841.
- Results publication: PubMed 31382666Ksiazek 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.
- Results publication: PubMed 23760056Ogan D, Pritchett K. Vitamin D and the athlete: risks, recommendations, and benefits. Nutrients. 2013 May 28;5(6):1856-68. doi: 10.3390/nu5061856.
- Results publication: PubMed 20924748Stockton 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.
- Results publication: PubMed 25156880Tomlinson 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.
- Results publication: PubMed 31752277Wicinski 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.
- Results publication: PubMed 32102188de 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.
- Individual participant dataSharing planned: No
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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.
Donna O Burnett, PhD study chair
Auburn University
Questions about this trial
What is this clinical trial studying?
A study testing Nature Made Vitamin D3 5,000 IU, 125mcg in people with Nutrition Status and Nutritional Requirements, run by Auburn University.
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 11 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: status not confirmed, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nilophar L Zandieh, MS (9492447504, nlz0005@auburn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodex Strength performance change (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05489666, which also lists 12 linked publications.
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 10 Aug 2022.