type 1 diabetes. Insulin-dependent diabetes mellitus
Conditions
Interventions
Intervention 1: Intervention group, alfacalcidol, 0.25 microgram, 2 times daily for 6 months. Intervention 2: Control group, placebo capsules, 2 times daily for 6 months.
Treatment - Drugs
Placebo
Intervention group, alfacalcidol, 0.25 microgram, 2 times daily for 6 months
Control group, placebo capsules, 2 times daily for 6 months
Sponsors
Endocrinology & Metabolism Research Institute, Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
8 Years to 18 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Age 8-18 years; Consecutively diagnosed as having T1DM according to the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus criteria; Without DKA; Duration of clinical disease (since the beginning of insulin therapy) less than 8 weeks; Without any medical co-morbidities or any other major chronic disease; Being on a stable diabetic diet therapy at least since 1 week ago Exclusion criteria: Cholecalciferol, calcium, multi-vitamin or mineral supplementation during the previous 3 months; Consuming some vitamin D-fortified foods; Hypercalcemia defined as total serum calcium higher than 10.8 mg/dl, at baseline or during follow-up.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum fasting C-peptide. Timepoint: months 0, 3, and 6 after intervention. Method of measurement: ELISA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose of insulin requirement. Timepoint: months 0, 3, and 6 after intervention. Method of measurement: Adjusted dose of insulin according to patients' blood glucose records. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAsal Ataie-Jafari
Endocrinology & Metabolism Research Institute, Tehran University of Medical Sciences
Outcome results
None listed