A Clinical Trial to Study the Effect of the Addition of Vitamin D to Conventional Treatment in New Pulmonary Tuberculosis Patients

Phase 3

Completed

• Conditions: Pulmonary Tuberculosis
• Interventions: Other: B. Migliol Oil without Cholecalciferol; Drug: A. 100,000 IU Cholecalciferol per dose of 3.3ml

• Registration Number: NCT00366470
• Lead Sponsor: Peter Daley

Brief Summary

There is some evidence that supplemental Vitamin D may contribute to quicker recovery from TB when given in addition to normal TB therapy. This needs to be proven with a controlled clinical trial. People receiving Vitamin D with anti TB therapy will be compared against people receiving anti TB therapy alone to see if vitamin D contributes to a quicker recovery (as shown by a quicker sputum culture conversion).

Detailed Description

The proposed study is a parallel, randomized, double-blinded, placebo-controlled clinical trial to quantify the change, if any, in microbiological outcome in TB patients treated with vitamin D in combination with standard DOTS therapy. It will take place in four South Indian DOTS centres. The required sample size is 250 patients receiving ATT, to be randomised in a 1:1 fashion (125 patients to receive vitamin D and 125 patients to receive placebo).

Study Timeline

• Study First Submitted: 2006-08-18
• Study First Submitted QC: 2006-08-18
• Study First Posted: 2006-08-21
• Study Start: 2009-11
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-04
• Last Update Posted: 2012-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Newly diagnosed smear positive pulmonary tuberculosis.
2. Age between 18 to 75 years
3. No pre-existing liver or renal disease
4. Available for return visits as outlined in the trial protocol
5. A Firm home address

Exclusion Criteria

1. Extra-pulmonary or smear negative tuberculosis
2. Patients receiving steroids, cytotoxic drugs, post transplant or metastatic malignancy, or not expected to survive for the duration of ATT
3. Pregnant or lactating women
4. Active diarrhoea, indicating possible fat-soluble vitamin malabsorption.
5. Baseline Hypercalcemia >10.5 mg/dl

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	B. Migliol Oil without Cholecalciferol	-
A	A. 100,000 IU Cholecalciferol per dose of 3.3ml	Vitamin D in doses of 100,000 IU

Primary Outcome Measures

Name	Time	Method
Time to sputum culture conversion	8 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Percent of Patients Culture Positive	8 Weeks
Performance Status	8 Weeks
Time To Sputum Smear Conversion	Continous
Proportion of Patients Smear Positive	4 Weeks, 8 Weeks, 12 Weeks
Time To Growth In Liquid Media	8 Weeks
RNTCP Treatment Outcomes	24 Weeks
Weight Gain	8 Weeks

Trial Locations

Locations (2)

Christian Medical College; 🇮🇳 Vellore, Tamil Nadu, India

Bethesda Hospital; 🇮🇳 Ambur, Tamilnadu, India