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Feasibility Study of 2000 IU Per Day of Vitamin D for the Primary Prevention of Type 1 Diabetes

NCT00141986 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2011-04-26

No results posted yet for this study

Summary

Type 1 diabetes is a common chronic disease of childhood. It is not yet preventable. Multiple daily injections of insulin, tests of blood sugar, and careful dietary planning are required lifelong to prevent long-term complications such as blindness and kidney failure. Recent studies of potential risk factors in children with diabetes, along with studies revealing the immunologic properties of vitamin D, and experiments in animals suggest higher doses of vitamin D may prevent type 1 diabetes. For proof for human children, a randomized trial will compare groups at risk randomly assigned to receive either the usual vitamin D supplement or a higher amount, 2000 IU daily. This initial study is a small scale test of procedures.

Conditions

Interventions

DIETARY_SUPPLEMENT

vitamin D3

2000 IU per day

DIETARY_SUPPLEMENT

vitamin D3

400 IU per os once daily

Sponsors & Collaborators

  • Manitoba Medical Service Foundation

    collaborator OTHER

  • Manitoba Institute of Child Health

    collaborator INDUSTRY

  • The Health Sciences Centre Medical Staff Council

    collaborator UNKNOWN

  • Canadian Diabetes Association

    lead OTHER

Principal Investigators

  • Shayne P Taback, MD FRCPC · University of Manitoba

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
4 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • Canada

Study Locations

More Related Trials

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 NCT00141986 on ClinicalTrials.gov