NCT00141986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

April 26, 2011

Status Verified

September 1, 2005

Enrollment Period

3.3 years

First QC Date

September 1, 2005

Last Update Submit

April 25, 2011

Conditions

Type 1 Diabetes

Keywords

vitamin Dtype 1 diabetesprevention trial

Outcome Measures

Primary Outcomes (1)

  • change in 25(OH)D from baseline

    25-hydroxyvitamin D levels

    at baseline (1 month of age), 2 months of age, 6 months of age, 9 months of age, 1 year of age

Secondary Outcomes (6)

  • renal ultrasound

    1 year of age

  • bone densitometry

    at 6 months and 1 year of age

  • diabetes autoantibody levels

    1 year of age

  • recruitment and retention rates

    1 year of age

  • Change from baseline in serum calcium levels

    at baseline (1 month of age), 2 months of age, 6 months of age, 9 months of age, 1 year of age

  • +1 more secondary outcomes

Study Arms (2)

Vitamin D-higher dose

EXPERIMENTAL

Vitamin D 2000 IU per os once daily

Dietary Supplement: vitamin D3

Vitamin D-lower dose

ACTIVE COMPARATOR

Vitamin D 400 IU per os once daily

Dietary Supplement: vitamin D3

Interventions

vitamin D3DIETARY_SUPPLEMENT

2000 IU per day

Also known as: cholecalciferol
Vitamin D-higher dose

Eligibility Criteria

AgeUp to 4 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manitoba Institute of Child Health

Winnipeg, Manitoba, Canada

Location

Related Publications (1)

  • Wicklow BA, Taback SP. Feasibility of a type 1 diabetes primary prevention trial using 2000 IU vitamin D3 in infants from the general population with increased HLA-associated risk. Ann N Y Acad Sci. 2006 Oct;1079:310-2. doi: 10.1196/annals.1375.047.

    PMID: 17130571RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Shayne P Taback, MD FRCPC

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

November 1, 2003

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

April 26, 2011

Record last verified: 2005-09

Locations

CA(1)