Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00141986
Status:
COMPLETED
Last Update Posted:
2011-04-26
First Post:
2005-09-01
Brief Title:
Feasibility Study of 2000 IU Per Day of Vitamin D for the Primary Prevention of Type 1 Diabetes
Sponsor:
Canadian Diabetes Association
Organization:
Canadian Diabetes Association
Study Overview
Official Title:
Pilot Trial of Vitamin D for the Prevention of Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 125-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 IUday instead of the current practice of 400 IUday 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 125-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
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 125-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 IUday instead of the current practice of 400 IUday 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 125-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None