Clinical trial NCT00366470: A Clinical Trial to Study the Effect of the Addition of Vitamin D to Conventional Treatment in New Pulmonary Tuberculosis Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Tuberculosis
Lead sponsor: Christian Medical College, Vellore, India
Sponsor class: OTHER
Collaborators: name: Dalhousie University
First posted: 2006-08-21
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Time to sputum culture conversion
timeFrame: 8 weeks of treatment
Secondary outcomes:
measure: Percent of Patients Culture Positive
timeFrame: 8 Weeks
measure: Performance Status
timeFrame: 8 Weeks
measure: Time To Sputum Smear Conversion
timeFrame: Continous
measure: Proportion of Patients Smear Positive
timeFrame: 4 Weeks, 8 Weeks, 12 Weeks
measure: Time To Growth In Liquid Media
timeFrame: 8 Weeks
measure: RNTCP Treatment Outcomes
timeFrame: 24 Weeks
measure: Weight Gain
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Vellore
country: India
facility: Christian Medical College
state: Tamil Nadu
city: Ambur
country: India
facility: Bethesda Hospital
state: Tamilnadu
Study officials:
affiliation: Christian Medical College, Vellore, India
name: Dilip Mathai, MD, FCAMS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daley P, Jagannathan V, John KR, Sarojini J, Latha A, Vieth R, Suzana S, Jeyaseelan L, Christopher DJ, Smieja M, Mathai D. Adjunctive vitamin D for treatment of active tuberculosis in India: a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2015 May;15(5):528-34. doi: 10.1016/S1473-3099(15)70053-8. Epub 2015 Apr 8.