Vitamin D Deficiency DiseaseNCT02954549
Vitamin D Supplementation in Warfighters
A study testing Vitamin D3 in people with Vitamin D Deficiency Disease, run by Madigan Army Medical Center at 1 site in United States.
Trial summary
A genomics-based approach will target specific genes that may explain the response in biomarkers and symptoms before and after supplementation. One objective is to generate evidence-based recommendations for vitamin D supplementation in Soldiers who often experience musculoskeletal disorders and immune dysfunction… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency Disease
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 29 Jun 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- active duty service member, age 18 years or older, ability to read and understand English, not deploying in the next 15 months, and subjectively in good health.
Who cannot join
- family members, beneficiaries, or civilians, pregnant or currently breastfeeding females, anyone with chronic health problems (e.g. eating disorders, kidney disease, liver disease, intestinal malabsorption), any active duty SM taking >400 IU/day vitamin D supplementation and unwilling to discontinue this, current or healing stress fractures, taking medications for an endocrine disorder, such as synthroid, or those identified as having a high potential for interaction with vitamin D including anti-seizure medications, cyclosporine, and indinavir (Crixivan).
Trial locations and contacts
1 site in 1 country.
United States1 site
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
Official title: Genomics of Vitamin D Supplementation and Warfighter Nutritional Resilience
A genomics-based approach will target specific genes that may explain the response in biomarkers and symptoms before and after supplementation. One objective is to generate evidence-based recommendations for vitamin D supplementation in Soldiers who often experience musculoskeletal disorders and immune dysfunction impacting physical performance and military readiness. The investigation is designed to address these specific aims: 1) explore vitamin D status in 105 Service Members to determine common symptoms associated with deficiency; 2) examine the effect of vitamin D levels on gene expression from select genes known to influence metabolism, bone density, and immune function; and 3) evaluate changes in gene expression between groups receiving high or low supplementation, and compare to healthy controls. Follow-up at 15 months will evaluate circulating vitamin D.
Read the detailed description
A genomics-based approach will target identified candidate genes and search for variants that may explain the response observed in biomarkers and symptoms when deficient individuals are repleted. The long-term objective of this study is to translate findings from next-generation sequencing (NGS) technology into clinically meaningful data regarding vitamin D supplementation for Service Members (SM) who may be at risk for musculoskeletal disorders and immune dysfunction that impacts physical performance and military readiness. We propose the following specific aims: 1) explore the phenotypic expression of vitamin D status in a cohort of SM to determine common symptoms associated with deficiency/insufficiency states; 2) examine the effect of vitamin D levels on broad gene expression from carefully chosen candidate genes known to influence vitamin D status, bone density, and immune function; 3) evaluate changes in gene expression levels between and within groups supplemented with low vs high vitamin D, and compare to healthy controls, and 4) examine the relationship between vitamin D deficiency and the clinically relevant outcomes of stress fracture and high blood pressure before and after supplementation to a therapeutic plasma level of 25(OH)D. This prospective, randomized, double-blind trial will enroll 105 SM in the Northwest to evaluate frequency, symptoms, and genomic expression of vitamin D levels using survey instruments, immunologic and bone biomarkers, and NGS of white blood cells pre- and post-supplementation with oral vitamin D over 3 months. Participant follow-up at 12 months will evaluate maintenance of adequate circulating vitamin D; this timeframe represents a typical deployment period.
- Conditions
- Vitamin D Deficiency Disease
- Being tested
- Vitamin D3
- Keywords
- vitamin D deficiency, genomics, vitamin D supplementation
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called Cholecalciferol
As in Arms
| Study group | Role | What they receive |
|---|---|---|
| Healthy control group | Active comparator | Subjects in this arm have a normal serum level of 25(OH)D, >30 ng/mL. Subjects submit to blood draws and biometric tests (DXA, body composition, BP) and questionnaires on 3 occasions. They do not receive vitamin D3 supplementation. Receives: Dietary Supplement: Vitamin D3 |
| Low dose supplementation group | Experimental | Subjects in this group have been identified as having a level of 25(OH)D of < 30 ng/mL and are randomized to receive vitamin D3 supplementation of 2000 IU daily for 3 months. Receives: Dietary Supplement: Vitamin D3 |
| High dose supplementation group | Experimental | Subjects in this group have been identified as having a level of 25(OH)D of <30 ng/mL and are randomized to receive vitamin D3 supplementation of 5000 IU daily for 3 months. Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
25(OH)D
Serum measure of 25(OH) at baseline, 3 months, and 15 months
Measured: 15 months
Secondary outcomes (1)
Vitamin D gene expression
Gene expression analysis will be used to determine relationship between low and high dose vitamin D supplementation and 25(OH)D levels, blood pressure, bone density, and body fat
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startJan 2016
- Primary completion29 Jun 2018
- Study completion29 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vitamin D Deficiency DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madigan Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- TriService Nursing Research Program
- Responsible party
- Sponsor
- Investigators
- Mary S McCarthy, PhD, Principal investigator, Madigan Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954549
- Sponsor's protocol ID
- HU001-15-1-TS05
- Status last verified
- May 2019
- First submitted
- 2 Nov 2016
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Fiscella K, Franks P. Vitamin D, race, and cardiovascular mortality: findings from a national US sample. Ann Fam Med. 2010 Jan-Feb;8(1):11-8. doi: 10.1370/afm.1035.
PubMed 20065273Yanovich R, Friedman E, Milgrom R, Oberman B, Freedman L, Moran DS. Candidate gene analysis in israeli soldiers with stress fractures. J Sports Sci Med. 2012 Mar 1;11(1):147-55. eCollection 2012.
PubMed 24149131Carlberg C. Genome-wide (over)view on the actions of vitamin D. Front Physiol. 2014 Apr 29;5:167. doi: 10.3389/fphys.2014.00167. eCollection 2014.
PubMed 24808867Hossein-nezhad A, Spira A, Holick MF. Influence of vitamin D status and vitamin D3 supplementation on genome wide expression of white blood cells: a randomized double-blind clinical trial. PLoS One. 2013;8(3):e58725. doi: 10.1371/journal.pone.0058725. Epub 2013 Mar 20.
PubMed 23527013
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomics of Vitamin D Supplementation and Warfighter Nutritional Resilience
- ClinicalTrials.gov ID
- NCT02954549
- Acronym / sponsor ID
- HU001-15-1-TS05
- Conditions
- Vitamin D Deficiency Disease
- Keywords
- vitamin D deficiency, genomics, vitamin D supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Madigan Army Medical CenterUS federal agency
- Collaborators
- TriService Nursing Research Program
- Study start
- Jan 2016 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 3 Nov 2016 (estimated)
- 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.
A genomics-based approach will target specific genes that may explain the response in biomarkers and symptoms before and after supplementation. One objective is to generate evidence-based recommendations for vitamin D supplementation in Soldiers who often experience musculoskeletal disorders and immune dysfunction impacting physical performance and military readiness. The investigation is designed to address these specific aims: 1) explore vitamin D status in 105 Service Members to determine common symptoms associated with deficiency; 2) examine the effect of vitamin D levels on gene expression from select genes known to influence metabolism, bone density, and immune function; and 3) evaluate changes in gene expression between groups receiving high or low supplementation, and compare to healthy controls. Follow-up at 15 months will evaluate circulating vitamin D.
Detailed description
A genomics-based approach will target identified candidate genes and search for variants that may explain the response observed in biomarkers and symptoms when deficient individuals are repleted. The long-term objective of this study is to translate findings from next-generation sequencing (NGS) technology into clinically meaningful data regarding vitamin D supplementation for Service Members (SM) who may be at risk for musculoskeletal disorders and immune dysfunction that impacts physical performance and military readiness. We propose the following specific aims: 1) explore the phenotypic expression of vitamin D status in a cohort of SM to determine common symptoms associated with deficiency/insufficiency states; 2) examine the effect of vitamin D levels on broad gene expression from carefully chosen candidate genes known to influence vitamin D status, bone density, and immune function; 3) evaluate changes in gene expression levels between and within groups supplemented with low vs high vitamin D, and compare to healthy controls, and 4) examine the relationship between vitamin D deficiency and the clinically relevant outcomes of stress fracture and high blood pressure before and after supplementation to a therapeutic plasma level of 25(OH)D. This prospective, randomized, double-blind trial will enroll 105 SM in the Northwest to evaluate frequency, symptoms, and genomic expression of vitamin D levels using survey instruments, immunologic and bone biomarkers, and NGS of white blood cells pre- and post-supplementation with oral vitamin D over 3 months. Participant follow-up at 12 months will evaluate maintenance of adequate circulating vitamin D; this timeframe represents a typical deployment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control group | Active comparator | Dietary Supplement: Vitamin D3Subjects in this arm have a normal serum level of 25(OH)D, >30 ng/mL. Subjects submit to blood draws and biometric tests (DXA, body composition, BP) and questionnaires on 3 occasions. They do not receive vitamin D3 supplementation. |
| Low dose supplementation group | Experimental | Dietary Supplement: Vitamin D3Subjects in this group have been identified as having a level of 25(OH)D of < 30 ng/mL and are randomized to receive vitamin D3 supplementation of 2000 IU daily for 3 months. |
| High dose supplementation group | Experimental | Dietary Supplement: Vitamin D3Subjects in this group have been identified as having a level of 25(OH)D of <30 ng/mL and are randomized to receive vitamin D3 supplementation of 5000 IU daily for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- active duty service member, age 18 years or older, ability to read and understand English, not deploying in the next 15 months, and subjectively in good health.
Key exclusion criteria (1 listed)
- family members, beneficiaries, or civilians, pregnant or currently breastfeeding females, anyone with chronic health problems (e.g. eating disorders, kidney disease, liver disease, intestinal malabsorption), any active duty SM taking >400 IU/day vitamin D supplementation and unwilling to discontinue this, current or healing stress fractures, taking medications for an endocrine disorder, such as synthroid, or those identified as having a high potential for interaction with vitamin D including anti-seizure medications, cyclosporine, and indinavir (Crixivan).
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 |
|---|---|---|
| Vitamin D3Also: CholecalciferolAs in Arms | Dietary supplement | Healthy control group, High dose supplementation group, Low dose supplementation group |
Primary outcome
25(OH)D
Time frame: 15 months
Serum measure of 25(OH) at baseline, 3 months, and 15 months
1 secondary outcome
Vitamin D gene expression
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Background: PubMed 20065273Fiscella K, Franks P. Vitamin D, race, and cardiovascular mortality: findings from a national US sample. Ann Fam Med. 2010 Jan-Feb;8(1):11-8. doi: 10.1370/afm.1035.
- Background: PubMed 24149131Yanovich R, Friedman E, Milgrom R, Oberman B, Freedman L, Moran DS. Candidate gene analysis in israeli soldiers with stress fractures. J Sports Sci Med. 2012 Mar 1;11(1):147-55. eCollection 2012.
- Background: PubMed 24808867Carlberg C. Genome-wide (over)view on the actions of vitamin D. Front Physiol. 2014 Apr 29;5:167. doi: 10.3389/fphys.2014.00167. eCollection 2014.
- Results publication: PubMed 23527013Hossein-nezhad A, Spira A, Holick MF. Influence of vitamin D status and vitamin D3 supplementation on genome wide expression of white blood cells: a randomized double-blind clinical trial. PLoS One. 2013;8(3):e58725. doi: 10.1371/journal.pone.0058725. Epub 2013 Mar 20.
- 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.
Mary S McCarthy, PhD principal investigator
Madigan Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Vitamin D Deficiency Disease, run by Madigan Army Medical Center at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
25(OH)D (time frame: 15 months). 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 NCT02954549, which also lists 4 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 May 2019; AzTrials last refreshed its copy on 31 Oct 2026.