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Prevention of relapse in Category I treated Pulmonary Tuberculosis patients with and without Vitamin D3 supplementation

Prevention of relapse in Category I treated Pulmonary Tuberculosis patients with & without Vitamin D3 supplementation A randomized double blind control clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/030977
Enrollment
800
Registered
2021-02-03
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: null- Tuberculosis patients-stable

Interventions

Intervention1: Cholicalciferol Sachet 60000 IU (Vitamin D): Subjects in the active intervention arm receive a cholecalciferol sachet orally (60, 000 IU D3/week for first 8 weeks and then monthly to co

Sponsors

Department of Health Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age �15 years Diagnosed PTB CAT I case as per RNTCP guidelines Able to give informed written consent Willing to participate in the study No major medical or surgical illness

Exclusion criteria

Exclusion criteria: Not willing to participate Age > 60 years With major medical or surgical illness Chronic Alcoholic Pregnancy &lactation, On vitamin D and calcium supplementation On any other drug affecting bone mineral homeostasis during past six months, Any other clinically overt disease Body mass index (BMI) Seriously ill patients requiring hospitalization

Design outcomes

Primary

MeasureTime frame
To study the effect of vitamin D3 supplementation in the prevention of relapse in category1 (CAT1) treated pulmonary Tuberculosis patientTimepoint: 6 months, 12 months

Secondary

MeasureTime frame
Assessment of TB relapse will be done in patients at the end to study periodTimepoint: 3 yrs

Countries

India

Contacts

Public ContactDr Himanshu Thukral

AIIMS

irtaiims@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 9, 2026