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Vitamin D Supplementation in the Armed Forces

NCT03963128 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4450

Last updated 2019-05-24

No results posted yet for this study

Summary

The study will comprise of an original investigation that will take the form of a prospective intervention (two matched groups) study. Condition-1 will be a vitamin D supplementation group (50.000 IU every two months), and Condition-2 will be a placebo supplementation group.

The primary research aim of this project is to evaluate the effectiveness of vitamin D supplementation to reduce stress fracture risk and susceptibility to skin, soft tissue infection (SSTI) and respiratory infection in Royal Marine recruits undertaking arduous physical training in a randomised control trial (RCT). The secondary research aims are:

1. To investigate whether supplementation of vitamin D3 at a dose of 50.000 IU every two months (equivalent to 800 IU per day) is effective in reducing the risk of stress fracture and susceptibility to skin, soft tissue and respiratory infection.
2. To examine changes in vitamin D status (relative to baseline serum 25(OH)D concentration), serum PTH concentration, and markers of bone turnover in response to vitamin D3 supplementation during the winter and summer months.
3. To identify interactions between dietary intakes, physical fitness, physical characteristics (body mass, BMI, thigh girth), smoking habit, alcohol consumption, and stress fracture prevalence with serum 25(OH)D status, serum PTH concentration and markers of bone turnover in the vitamin D3 supplemented group vs. the placebo supplemented group.

Conditions

Interventions

DIETARY_SUPPLEMENT

Supplementation Vitamin D3

Supplementation of vitamin D3 at a dose of 50.000 IU administered every two months (equivalent of 800 IU per day)

DIETARY_SUPPLEMENT

Placebo

Placebo administred every two months

Sponsors & Collaborators

  • Institute of Naval Medicine

    collaborator UNKNOWN

  • CTRM Lympstone

    collaborator UNKNOWN

  • Navy Command Headquarters

    collaborator UNKNOWN

  • University of Surrey

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
16 Years
Max Age
32 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-06
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03963128 on ClinicalTrials.gov