Vitamin D Supplementation in Warfighters

NCT02954549 | Completed DMC

• 1 other identifier: HU001-15-1-TS05
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency Disease

Keywords

vitamin D deficiency, genomics, vitamin D supplementation

Outcome Measures

Primary Outcomes (1)

• 25(OH)D

  Serum measure of 25(OH) at baseline, 3 months, and 15 months

  15 months

Secondary Outcomes (1)

• Vitamin D gene expression

  3 months

Study Arms (3)

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.

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.

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.

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

As in Arms

Also known as: Cholecalciferol

Healthy control group; High dose supplementation group; Low dose supplementation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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).

Sponsors & Collaborators

• Madigan Army Medical Center: lead
• TriService Nursing Research Program: collaborator

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (4)

• 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.

  PMID: 20065273 BACKGROUND

• Yanovich 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.

  PMID: 24149131 BACKGROUND

• Carlberg 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.

  PMID: 24808867 BACKGROUND

• Hossein-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.

  PMID: 23527013 RESULT

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Mary S McCarthy, PhD

  Madigan Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 3, 2016
• Study Start: January 1, 2016
• Primary Completion: June 29, 2018
• Study Completion: June 29, 2018
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)