Vitamin D Supplementation D_SAF Pilot Study
Vitamin D Supplementation in the Armed Forces (D_SAF) PILOT STUDY
1 other identifier
interventional
532
1 country
2
Brief Summary
This study is a randomised control trial (RCT) pilot study to determine the appropriate vitamin D dose for the main study. The pilot study includes three matched groups, which will form two vitamin D supplementation groups (at 25,000 IU and 50,000 IU every two months), and a third placebo supplementation group. The aim was to develop an appropriate supplementation regimen that was compatible with recruit training and maintained serum vitamin D (25OHD) status above 50 nmol/l during recruit training.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2016
CompletedFirst Submitted
Initial submission to the registry
July 23, 2019
CompletedFirst Posted
Study publicly available on registry
July 26, 2019
CompletedJuly 26, 2019
July 1, 2019
1.5 years
July 23, 2019
July 25, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
The dose-response changes in 25-hydroxyvitamin D
32 weeks
The incidence of injury/illness in recruits during training
32 weeks
Study Arms (3)
25,000 IU
ACTIVE COMPARATOR50,000 IU
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Vitamin-D3 supplementation providing 25,000 IU administered orally every two months (equivalent to \~400 IU/d);
Vitamin-D3 supplementation providing 50,000 IU administered orally every two months (equivalent to \~800 IU/d);
A placebo (administered orally every two months) supplementation control group.
Eligibility Criteria
You may qualify if:
- RM recruit troops commencing training during the winter and summer months,
- aged between 16 - 32 years at the Start of Training
- having successfully completed the physical and professional selection tests which comprise the Potential Royal Marine Course (PRMC)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Surreylead
- Institute of Naval Medicinecollaborator
- CTRM Lympstonecollaborator
- Navy Command Headquarterscollaborator
Study Sites (2)
University of Surrey
Guildford, Surrey, GU2 7XH, United Kingdom
Institute of Naval Medicine
Gosport, PO12 2DL, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joanne L Fallowfield, PhD
Institute of Naval Medicine
- PRINCIPAL INVESTIGATOR
Susan A Lanham-New, Professor
University of Surrey
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
Study Record Dates
First Submitted
July 23, 2019
First Posted
July 26, 2019
Study Start
December 1, 2014
Primary Completion
June 10, 2016
Study Completion
June 10, 2016
Last Updated
July 26, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share