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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00141986
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : April 26, 2011
Manitoba Medical Service Foundation
Manitoba Institute of Child Health
The Health Sciences Centre Medical Staff Council
Information provided by:
Canadian Diabetes Association

Brief 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Dietary Supplement: vitamin D3 Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Trial of Vitamin D for the Prevention of Type 1 Diabetes
Study Start Date : November 2003
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Vitamin D-higher dose
Vitamin D 2000 IU per os once daily
Dietary Supplement: vitamin D3
2000 IU per day
Other Name: cholecalciferol

Active Comparator: Vitamin D-lower dose
Vitamin D 400 IU per os once daily
Dietary Supplement: vitamin D3
400 IU per os once daily
Other Name: Cholecalciferol

Primary Outcome Measures :
  1. change in 25(OH)D from baseline [ Time Frame: at baseline (1 month of age), 2 months of age, 6 months of age, 9 months of age, 1 year of age ]
    25-hydroxyvitamin D levels

Secondary Outcome Measures :
  1. renal ultrasound [ Time Frame: 1 year of age ]
    to detect nephrocalcinosis

  2. bone densitometry [ Time Frame: at 6 months and 1 year of age ]
  3. diabetes autoantibody levels [ Time Frame: 1 year of age ]
    GADA, ICA-512, IAA

  4. recruitment and retention rates [ Time Frame: 1 year of age ]
  5. Change from baseline in serum calcium levels [ Time Frame: at baseline (1 month of age), 2 months of age, 6 months of age, 9 months of age, 1 year of age ]
  6. changes in urine calcium:creatinine ratio [ Time Frame: monthly in the first year of life ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HLA genotypes that increase risk of type 1 diabetes: heterozygous for DRB1*03, DQA1*0501, DQB1*0201 / DRB1*04, DQA1*03011, DQB1*0302 (DRB1*04 ≠ *0403 or related alleles), or homozygous for DRB1*03, DQA1*0501, DQB1*0201, or homozygous for DRB1*04, DQA1*03011, DQB1*0302 (DRB1*04 ≠ *0403 or related alleles).

Exclusion Criteria:

  • Premature, low birthweight, or major congenital malformations or serious chronic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00141986

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Canada, Manitoba
Manitoba Institute of Child Health
Winnipeg, Manitoba, Canada
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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Principal Investigator: Shayne P Taback, MD FRCPC University of Manitoba
Publications of Results:
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Responsible Party: Shayne P. Taback, University of Manitoba Identifier: NCT00141986    
Other Study ID Numbers: 1622
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: April 26, 2011
Last Verified: September 2005
Keywords provided by Canadian Diabetes Association:
vitamin D
type 1 diabetes
prevention trial
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents