How Much Vitamin D is Required to be Protective Against Deficiency During the Winter Months?

NCT01437696 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2014-09-05

No results posted yet for this study

Summary

Vitamin D is essential to bone health. In Canada, it is obtained by sunlight exposure of the skin (between April and October) or by a few foods such as fatty fish, eggs or fortified milk and margarine. This study has 3 main goals which are to determine if Veteran's have enough vitamin D stored in their body, if adding a supplement of 2000 IU/d is enough to correct low vitamin D stores and, if specially formulated foods using an approved vitamin D supplement, are appropriate to maintain vitamin D stores in relation with functional and cognitive status. Initially, a 2000 IU supplement of vitamin D will be provided for 8 weeks. After this period, the participants will be randomly separated into 3 groups (Group A, B or C) for a period of 24 weeks. Group A will receive their usual menu. Group B will receive their usual menu with 1 portion of food containing 500 IU of added vitamin D. Group C will receive their usual menu with 1 portion of food containing 1000 IU of added vitamin D. Food intake will be assessed every 8 weeks and blood samples will be taken every 4 weeks to monitor change in blood concentration of vitamin D and other indicators of bone health. The investigators will document weight and height, hand grip strength, the mid-arm and mid-calf circumferences, the capacity to perform activities of daily living, the number of prescriptions and changes in health condition. The investigators will also take an X-ray the tibia and upper arm to document the amount and quality of bones in those regions. A total of 60 veterans of Ste-Anne's Hospital will participate in this study. Knowing more about vitamin D status and intake will help in confirming the required vitamin D recommendations for the elderly men living in long-term care institutions.

Conditions

  • Vitamin D Deficiency

Interventions

DIETARY_SUPPLEMENT

Vitamin D

A liquid cholecalciferol at a dosage of 500IU will be added to a specific food and provided to the participants once a day for 24 weeks.

DIETARY_SUPPLEMENT

Vitamin D

A liquid cholecalciferol at a dosage of 1000IU will be added to a specific food and provided to the participants once a day for 24 weeks.

OTHER

placebo

No liquid cholecalciferol will be added to the food.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • McGill University

    lead OTHER

Principal Investigators

  • Hope A Weiler, PhD, RD · McGill University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Canada

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Entities

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 NCT01437696 on ClinicalTrials.gov