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Vitamin D Supplementation D_SAF Pilot Study

NCT04033796 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 532

Last updated 2019-07-26

No results posted yet for this study

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.

Conditions

  • Vitamin D Deficiency

Interventions

DIETARY_SUPPLEMENT

25,000 IU

Vitamin-D3 supplementation providing 25,000 IU administered orally every two months (equivalent to \~400 IU/d);

DIETARY_SUPPLEMENT

50,000 IU

Vitamin-D3 supplementation providing 50,000 IU administered orally every two months (equivalent to \~800 IU/d);

DIETARY_SUPPLEMENT

Placebo

A placebo (administered orally every two months) supplementation control group.

Sponsors & Collaborators

  • Institute of Naval Medicine

    collaborator UNKNOWN

  • CTRM Lympstone

    collaborator UNKNOWN

  • Navy Command Headquarters

    collaborator UNKNOWN

  • University of Surrey

    lead OTHER

Principal Investigators

  • Joanne L Fallowfield, PhD · Institute of Naval Medicine

  • Susan A Lanham-New, Professor · University of Surrey

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
2014-12-01
Primary Completion
2016-06-10
Completion
2016-06-10

Countries

  • United Kingdom

Study Locations

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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 NCT04033796 on ClinicalTrials.gov