By doing this study, weâ??re trying to find whether Zinc, which is a mineral supplement, anti inflammatory and increases the insulin secretion and decreases insulin requirement, can help decrease the disease activity, thereby reducing the complications of the disease and insulin requirement.
Phase 4
- Conditions
- Health Condition 1: E108- Type 1 diabetes mellitus with unspecified complications
- Registration Number
- CTRI/2023/06/053634
- Lead Sponsor
- JIPMER Intramural Research Grant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Type 1diabetes mellitus children diagnosed as per WHO criteria aged 3 to 18 years with minimum duration from diagnosis of 6 months
Exclusion Criteria
Patients who were treated with zinc for other illnesses in the last 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of daily zinc (20mg) supplementation on change in HbA1c level.Timepoint: 4 weeks, 8 weeks, 12 weeks
- Secondary Outcome Measures
Name Time Method 1)To analyze the effect of zinc supplementation on the antioxidant activity <br/ ><br>2)To analyze the effect of zinc supplementation on autoantibodies in Type 1 DM 3)To analyze the effect of zinc supplementation on c-peptide levels <br/ ><br>4)To analyze the effect of zinc supplementation on lipid profile <br/ ><br>Timepoint: 4 weeks, 8 weeks, 12 weeks