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Sponsors and Collaborators: |
Canadian Diabetes Association Manitoba Medical Service Foundation Manitoba Institute of Child Health The Health Sciences Centre Medical Staff Council |
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Information provided by: | Canadian Diabetes Association |
ClinicalTrials.gov Identifier: | NCT00141986 |
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.
Condition | Intervention | Phase |
---|---|---|
Type 1 Diabetes |
Drug: vitamin D3 (cholecalciferol) 2000 IU per day |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | Pilot Trial of Vitamin D for the Prevention of Type 1 Diabetes |
Estimated Enrollment: | 20 |
Study Start Date: | November 2003 |
Estimated Study Completion Date: | September 2007 |
Type 1 diabetes is a multifactorial disease with both strong genetic and non-genetic components of disease susceptibility. The uniquely strong genetic risk factor region, the human leukocyte antigen region on chromosome 6p, contributes approximately half of the genetic component and can be used for screening for diabetes risk. For example, individuals with the highest risk compound heterozygote genotype comprise 2% of the general population, but have a twenty fold increased risk for type 1 diabetes with an absolute risk of approximately 7% by age 15 years.
Studies of the non-inherited component of diabetes susceptibility implicate external environmental factors operating in the first year of life, suggesting the possibility to reverse the trend with the correct intervention. Recent data suggest that the vitamin D system is a potentially important target for therapeutic intervention to prevent type 1 diabetes. These data include epidemiological studies showing that vitamin D supplementation in infancy is associated with a substantially decreased subsequent risk of the disease, and animal work in the non-obese diabetes mouse model of autoimmune diabetes showing that the incidence of autoimmune diabetes increases when the animals are nutritionally deprived of vitamin D, and that the disease can be prevented using 1,25-dihydroxyvitamin D, and non-hypercalcemic vitamin D analogues. In vitro experiments suggest that the prevention seen in NOD mice may be due to combined effects of vitamin D on antigen presenting cells and activated T-cells.
Based on these epidemiological and animal model studies, we hypothesize that administration during infancy of cholecalciferol, the usual nutritional supplement form of vitamin D, at the increased dose of 2000 IU/day (instead of the current practice of 400 IU/day) will prevent type 1 diabetes in children from the general population at increased genetic risk.
The main objective of this proposal is to pilot a two-arm randomized controlled trial comparing these two doses. The participants are infants from the general population identified at increased genetic risk for type 1 diabetes by cord blood or filter paper blood spot HLA class II genetic screening. The study will measure key safety, compliance and pharmacokinetic, surrogate efficacy, and process outcomes including growth parameters, 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D levels, calcium levels in blood and urine, bone mineral content and body composition by densitometry, diabetes-related autoantibodies markers for beta-cell autoimmunity, and recruitment rates for both the screening and for the intervention trial.
Ages Eligible for Study: | up to 4 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dan Catte, RD | 977-5645 | dcatte@mich.ca |
Contact: Lori D Berard, RN | 204-789-3228 | lberard@hsc.mb.ca |
Canada, Manitoba | |
Manitoba Institute of Child Health | Recruiting |
Winnipeg, Manitoba, Canada | |
Contact: Daniel Catte dcatte@mich.ca | |
Contact: Lori Berard lberard@hsc.mb.ca | |
Principal Investigator: Shayne P Taback, MD FRCPC | |
Sub-Investigator: Hope A Weiler, PhD | |
Sub-Investigator: Cheryl Rockman-Greenberg, MD FRCPC | |
Sub-Investigator: Heather J Dean, MD FRCPC | |
Sub-Investigator: Tom Blydt-Hansen, MD FRCPC |
Principal Investigator: | Shayne P Taback, MD FRCPC | University of Manitoba |
Study ID Numbers: | 1622 |
Study First Received: | September 1, 2005 |
Last Updated: | September 1, 2005 |
ClinicalTrials.gov Identifier: | NCT00141986 |
Health Authority: | Canada: Health Canada |
vitamin D type 1 diabetes prevention trial |
Cholecalciferol Vitamin D Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Ergocalciferols |
Diabetes Mellitus Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Immune System Diseases Growth Substances Vitamins Physiological Effects of Drugs |
Bone Density Conservation Agents Micronutrients Pharmacologic Actions |