Vitamin D Supplementation in the Armed Forces

NCT03963128 | Unknown

• 1 other identifier: D_SAF
• Study Type: interventional
• Target: 4,450
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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

Stress Fracture; Injury

Keywords

Vitamin D; Royal Marines; Military Training; Illness

Outcome Measures

Primary Outcomes (1)

• The effectiveness of supplementation of vitamin D3 at a dose of 50.000 IU administered every two months (equivalent of 800 IU per day) in reducing the risk of stress fracture.

  32 weeks

Secondary Outcomes (9)

• The effectiveness of supplementation of vitamin D3 at a dose of 50.000 IU administered every two months (equivalent of 800 IU per day) in reducing the risk of susceptibility to skin infection.

  32 weeks

• The effectiveness of supplementation of vitamin D3 at a dose of 50.000 IU administered every two months (equivalent of 800 IU per day) in reducing the risk of susceptibility to soft tissue (SSTI) infection.

  2018 - 2023

• The effectiveness of supplementation of vitamin D3 at a dose of 50.000 IU administered every two months (equivalent of 800 IU per day) in reducing the risk of respiratory infection.

  32 weeks

• Changes in vitamin D status (relative to baseline serum 25(OH)D concentration) in response to vitamin D3 supplementation during the winter and summer months.

  32 weeks

• Changes in serum PTH concentration (relative to baseline concentration) in response to vitamin D3 supplementation during the winter and summer months.

  32 weeks

Study Arms (2)

Supplemented Vitamin D3

ACTIVE COMPARATOR

Dietary Supplement: Supplementation Vitamin D3

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Supplementation Vitamin D3 DIETARY_SUPPLEMENT

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

Supplemented Vitamin D3

Placebo DIETARY_SUPPLEMENT

Placebo administred every two months

Placebo

Eligibility Criteria

• Age: 16 Years - 32 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Royal Marines
• aged between 16 - 32 years at the Start of Training,
• successfully completed the physical and professional selection tests which comprise the Potential Royal Marine Course (PRMC), and be deemed medically fit and healthy following medical screening at the AFCO and again at CTC if required.

You may not qualify if:

• not participating in Recruit Syllabus (RS10) for RM recruit training
• deemed unsuitable by the IMO or the training team.

Sponsors & Collaborators

• University of Surrey: lead
• Institute of Naval Medicine: collaborator
• CTRM Lympstone: collaborator
• Navy Command Headquarters: collaborator

Study Sites (1)

Institute of Naval Medicine

Gosport, United Kingdom

RECRUITING

MeSH Terms

Conditions

Fractures, Stress; Wounds and Injuries

Condition Hierarchy (Ancestors)

Fractures, Bone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Human Nutrition & Head, Nutritional Sciences Department

Model Details: Recruited cohort divided into two groups: (i) a vitamin-D3 supplementation (50,000 IU administred every two months); and (ii) a placebo supplementation (administered orally every two months) control group.

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 24, 2019
• Study Start: November 6, 2017
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 24, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)