Vitamin D Supplementation in Warfighters
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/6/2017 |
| Start Date: | January 2016 |
| End Date: | September 2018 |
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.
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.
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.
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.
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).
We found this trial at
1
site
Madigan Army Medical Center Located on Joint Base Lewis-McChord, Madigan Army Medical Center comprises a...
Click here to add this to my saved trials
