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

Effect of vitamin D supplementation on treatment response and IL-10 level in vitamin D deficient parthenium dermatitis patients â?? a randomized double blind placebo controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/02/006626
Enrollment
90
Registered
2016-02-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Parthenium dermatitis patients with Vitamin D deficiency

Interventions

Intervention1: Vitamin D: Tablet Vitamin D 60,000 IU / week for 2 months in addition to Standard background therapy (Tab. Azathioprine) Control Intervention1: Placebo: Similar looking placebo tablet

Sponsors

JIPMER Intramural fund
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Clinically diagnosed Parthenium dermatitis patients to be started on systemic treatment with azathioprine Vitamin D deficiency (10-20 ng/ml)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
IL-10 levels, disease severity scoring (EASI-Erythema Area Severity Index)Timepoint: IL-10 - At baseline and after 2 months Disease severity - At baseline, At the end of 1st month, 2nd month and 3rd month

Secondary

MeasureTime frame
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

Countries

India

Contacts

Public ContactLaxmisha C

JIPMER

sandhiyaselvarajan@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026