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Role of Vitamin D supplementation in the treatment response for parthenium dermatitis

Phase 4
Completed
Conditions
Health Condition 1: null- Parthenium dermatitis patients with Vitamin D deficiency
Registration Number
CTRI/2016/02/006626
Lead Sponsor
JIPMER Intramural fund
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
72
Inclusion Criteria

Clinically diagnosed Parthenium dermatitis patients to be started on systemic treatment with azathioprine

Vitamin D deficiency (10-20 ng/ml)

Exclusion Criteria

Pregnant and lactating women

Individuals already on vitamin D supplementation

Liver dysfunction (AST, ALT > 1.5 times the upper limit of normal)

Renal dysfunction (Serum creatinine, blood urea > 1.5 times the upper limit of normal)

Patients who had participated in other trials within last 3 months

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
IL-10 levels, disease severity scoring (EASI-Erythema Area Severity Index)Timepoint: IL-10 - At baseline and after 2 months <br/ ><br>Disease severity - At baseline, At the end of 1st month, 2nd month and 3rd month
Secondary Outcome Measures
NameTimeMethod
Adherence to medicationTimepoint: At the end of each month till six months;Frequency of relapsesTimepoint: At the end of each month till six months;Need for rescue medicationsTimepoint: At the end of each month till six months;Quality of life indexTimepoint: At baseline, At the end of 1st month, 2nd month and 3rd month
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