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: The study will be conducted in Newly Diagnosed Sputum Positive Pulmonary Tuberculosis patients.

• Registration Number: CTRI/2007/091/000008
• Lead Sponsor: Christian Medical College,Vellore

Brief Summary

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 CMC DOTS centres ,TB clinic at Bethestha hospital,Ambur,Scudder memorial hospital,Ranipet,Adukambarai ,GH,TB clinics all around ,Velore. 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). Primary outcome is Time to sputum culture conversion at 8 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-11
• Last Update Posted: 2014-06-23

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 250

Inclusion Criteria

• 1.Newly diagnosed smear positive pulmonary tuberculosis, including previously treated2.Age between 18 to 75 years3.No pre-existing liver or renal disease4.Consent given for HIV testing5.Available for return visits as outlined in the trial protocol6.
• 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.HIV infection4.Pregnant or lactating women 5.
• Active diarrhoea, indicating possible fat-soluble vitamin malabsorption.
• 6.Baseline Hypercalcemia (>10.5 mg/dl).

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to sputum culture conversion	8 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of patients culture positive	8 weeks
Performance status	8 weeks
TIme to sputum smear conversion	continuous
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 (4)

Bedestha Hospital; 🇮🇳 India

CMC DOTS Centres; 🇮🇳 Vellore, TAMIL NADU, India

CMC-CHAD Hospital; 🇮🇳 Vellore, TAMIL NADU, India

TB Clinics Around Vellore; 🇮🇳 Vellore, TAMIL NADU, India

Bedestha Hospital

🇮🇳India

Dr. Joel Nesaraj

Principal investigator

joelnesraj@rediffmail.com