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

Pulmonary Tuberculosis Clinical Trial

Official title:

A Double Blind, Randomized, Parallel, Placebo Control Design Study to Determine the Effect of Addition of Vitamin D to Conventional Anti TB Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366470
• Other study ID #: TB-VitaminD
• Secondary ID: CTRI/2007/091/00
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2006
• Last updated: July 4, 2012
• Start date: November 2009
• Est. completion date: May 2012

Study information

• Verified date: July 2012
• Source: Christian Medical College, Vellore, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Drug:
• A. 100,000 IU Cholecalciferol per dose of 3.3ml
100,000 IU Cholecalciferol in 3.3ml Migliol (Carrier) oil, once every two weeks for 2 Months

Other:
• B. Migliol Oil without Cholecalciferol
3.3 ml Migliol Oil, every two weeks for two months

Locations

Country	Name	City	State
India	Bethesda Hospital	Ambur	Tamilnadu
India	Christian Medical College	Vellore	Tamil Nadu

Sponsors (2)

Lead Sponsor	Collaborator
Peter Daley	Dalhousie University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to sputum culture conversion		8 weeks of treatment	Yes
Secondary	Percent of Patients Culture Positive		8 Weeks	Yes
Secondary	Performance Status		8 Weeks	Yes
Secondary	Time To Sputum Smear Conversion		Continous	Yes
Secondary	Proportion of Patients Smear Positive		4 Weeks, 8 Weeks, 12 Weeks	Yes
Secondary	Time To Growth In Liquid Media		8 Weeks	No
Secondary	RNTCP Treatment Outcomes		24 Weeks	Yes
Secondary	Weight Gain		8 Weeks	Yes