Efficacy of Calcitriol in Recent Onset Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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Reduction in vitamin D levels has been reported in subjects with recent onset type 1 diabetes. Several studies suggest that vitamin D supplementation in early childhood decreases the risk of developing type 1 diabetes, therefore vitamin D deficiency might play a role in the disease pathogenesis. We investigated whether the supplementation of the active form of vitamin D (calcitriol) in subjects with recent-onset type 1 diabetes can protect residual beta cell function evaluated by C peptide and improve glycaemic control as evaluated by HbA1c and insulin requirement.

Thirty-four subjects (age range 11-35 years, median 18 years) with recent-onset type 1 diabetes (\<12 weeks duration) and high basal C-peptide \>0.25 nmol/l were randomized in a double-blind trial to calcitriol (the active form of vitamin D, 1.25-dihydroxyvitamin D3 \[1,25-(OH)2D3\] ) at the dose of 0.25 ug/day or placebo, and followed up for 2 years.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Groups

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Calcitriol

Group Type EXPERIMENTAL

Calcitriol

Intervention Type DRUG

placebo

Group Type PLACEBO_COMPARATOR

Calcitriol

Intervention Type DRUG

Interventions

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Calcitriol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. diagnosis of type 1 diabetes according to the American Diabetes Association (ADA) guidelines;
2. age at presentation between 11 and 35 years;
3. duration of clinical disease (since the beginning of insulin therapy) \<12 weeks;
4. baseline C-peptide \>0.25 nmol/l;
5. no medical contra-indications or any other major chronic disease;
6. willingness and capability to participate in a regular follow-up.

Exclusion Criteria

1. cardiovascular disease;
2. renal disease;
3. liver disease;
4. neurological disorders;
5. allergic diathesis;
6. hyperparathyroidism;
7. neoplasia.

Minimum Eligible Age

11 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No