Type 1 Diabetes Clinical Trial
Official title:
Pilot Trial of Vitamin D for the Prevention of Type 1 Diabetes
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05653518 -
Artificial Pancreas Technology to Reduce Glycemic Variability and Improve Cardiovascular Health in Type 1 Diabetes
|
N/A | |
Enrolling by invitation |
NCT05515939 -
Evaluating the InPen in Pediatric Type 1 Diabetes
|
||
Completed |
NCT05109520 -
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
|
||
Recruiting |
NCT04016987 -
Automated Structured Education Based on an App and AI in Chinese Patients With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT04190368 -
Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes
|
N/A | |
Recruiting |
NCT05413005 -
Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
|
Early Phase 1 | |
Active, not recruiting |
NCT04668612 -
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
|
N/A | |
Completed |
NCT02837094 -
Enhanced Epidermal Antigen Specific Immunotherapy Trial -1
|
Phase 1 | |
Recruiting |
NCT05414409 -
The Gut Microbiome in Type 1 Diabetes and Mechanism of Metformin Action
|
Phase 2 | |
Recruiting |
NCT05670366 -
The Integration of Physical Activity Into the Clinical Decision Process of People With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT05418699 -
Real-life Data From Diabetic Patients on Closed-loop Pumps
|
||
Completed |
NCT04084171 -
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
|
N/A | |
Recruiting |
NCT06144554 -
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
|
||
Recruiting |
NCT05153070 -
Ciclosporin Followed by Low-dose IL-2 in Patients With Recently Diagnosed Type 1 Diabetes
|
Phase 2 | |
Recruiting |
NCT05379686 -
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
|
N/A | |
Completed |
NCT05281614 -
Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
|
Early Phase 1 | |
Withdrawn |
NCT04259775 -
Guided User-initiated Insulin Dose Enhancements (GUIDE) to Improve Outcomes for Youth With Type 1 Diabetes
|
N/A | |
Active, not recruiting |
NCT01600924 -
Study on the Assessment of Determinants of Muscle and Bone Strength Abnormalities in Diabetes
|
||
Completed |
NCT02897557 -
Insulet Artificial Pancreas Early Feasibility Study
|
N/A | |
Completed |
NCT02855307 -
Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
|
Phase 2 |