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Vitamin D Supplementation in Warfighters

Genomics of Vitamin D Supplementation and Warfighter Nutritional Resilience

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02954549
Enrollment
131
Registered
2016-11-03
Start date
2016-01-31
Completion date
2018-06-29
Last updated
2019-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency Disease

Keywords

vitamin D deficiency, genomics, vitamin D supplementation

Brief 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 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.

Interventions

DIETARY_SUPPLEMENTVitamin D3

As in Arms

Sponsors

TriService Nursing Research Program
CollaboratorOTHER
Madigan Army Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

\- 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.

Exclusion criteria

\- 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).

Design outcomes

Primary

MeasureTime frameDescription
25(OH)D15 monthsSerum measure of 25(OH) at baseline, 3 months, and 15 months

Secondary

MeasureTime frameDescription
Vitamin D gene expression3 monthsGene 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026