None listed
Conditions
Interventions
Intervention1: Vitamin D fortified milk: Cholecalciferol 600 units and 1000 units per day
Control Intervention1: unfortified milk: unfortified milk
Sponsors
DSM Nutritional Products India Pvt Ltd
International Life Sciences InstituteIndia
Eligibility
Inclusion criteria
Inclusion criteria: Subjects in the age group of 10-14 years.
Exclusion criteria
Exclusion criteria: Exclusion criteria: Subjects will be excluded from the study if they • Have past or current history of renal stones • Are taking or had taken vitamin D supplementation in last six months in doses exceeding 600 IU/day • Have any systemic disease (cardiac, hepatic, endocrine or renal) or taking any kind of treatment more than one month in last six months. • Are diagnosed malabsorption (celiac disease, Crohnâ??s dis, ulcerative colitis) or history suggestive of malabsorption especially history of milk allergy. • Are using medications known to interact with vitamin D metabolism (steroids, thiazide diuretics, phenytoin, phenobarbitone, and antitubercular drugs) • Have known hypersensitivity to vitamin D preparation • Have participated in any other investigational drug study in previous three months • Have features suggestive of osteomalacia or severe vitamin D deficiency • Are using Ultra-Violet (UV) radiations as a part of medical therapy • Are diagnosed with albinism or have other condition associated with decreased skin pigmentation • Have any medical condition that in the judgment of the investigator would jeopardize the subjectâ??s safety or evaluation of study drug for efficacy or safety • Have serum calcium more than 1 mg/dL above the upper limit of normal for age • Have hypercalciuria as per definition • Have serum 25-hydroxy vitamin D level more than 100 ng/mL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in vitamin D status as measured by serum 25-hydroxy vitamin D [S25(OH)D] levels.Timepoint: baseline and six months after supplementation | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the effects of vitamin D supplementation on serum alkaline phosphatase, parathyroid hormone (PTH) levels and insulin resistance.Timepoint: baseline and six months after supplementation | — |
Countries
India
Contacts
Public ContactRajesh Khadgawat
All India Institute of Medical Sciences
Outcome results
None listed