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

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ClinicalTrials.gov Identifier: NCT00366470
Recruitment Status : Completed
First Posted : August 21, 2006
Last Update Posted : July 6, 2012
Sponsor:
Collaborator:
Dalhousie University
Information provided by (Responsible Party):
Peter Daley, Christian Medical College, Vellore, India

Tracking Information
First Submitted Date  ICMJE August 18, 2006
First Posted Date  ICMJE August 21, 2006
Last Update Posted Date July 6, 2012
Study Start Date  ICMJE November 2009
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2009)
Time to sputum culture conversion [ Time Frame: 8 weeks of treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2006)
time to sputum smear conversion (treatment and placebo)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2009)
  • Percent of Patients Culture Positive [ Time Frame: 8 Weeks ]
  • Performance Status [ Time Frame: 8 Weeks ]
  • Time To Sputum Smear Conversion [ Time Frame: Continous ]
  • Proportion of Patients Smear Positive [ Time Frame: 4 Weeks, 8 Weeks, 12 Weeks ]
  • Time To Growth In Liquid Media [ Time Frame: 8 Weeks ]
  • RNTCP Treatment Outcomes [ Time Frame: 24 Weeks ]
  • Weight Gain [ Time Frame: 8 Weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2006)
  • Proportion of patients smear positive at 1,2 and 3 months
  • Proportion of patients culture positive at two months
  • Time to growth of organisms
  • Treatment outcomes
  • Weight Gain
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Study the Effect of the Addition of Vitamin D to Conventional Treatment in New Pulmonary Tuberculosis Patients
Official Title  ICMJE A Double Blind, Randomized, Parallel, Placebo Control Design Study to Determine the Effect of Addition of Vitamin D to Conventional Anti TB Therapy
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Tuberculosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: A
    Vitamin D in doses of 100,000 IU
    Intervention: Drug: A. 100,000 IU Cholecalciferol per dose of 3.3ml
  • Placebo Comparator: B
    Intervention: Other: B. Migliol Oil without Cholecalciferol
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2009)
250
Original Enrollment  ICMJE
 (submitted: August 18, 2006)
340
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00366470
Other Study ID Numbers  ICMJE TB-VitaminD
CTRI/2007/091/000008 ( Registry Identifier: Clinical Trials Registry of India )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter Daley, Christian Medical College, Vellore, India
Study Sponsor  ICMJE Peter Daley
Collaborators  ICMJE Dalhousie University
Investigators  ICMJE
Principal Investigator: Dilip Mathai, MD, FCAMS Christian Medical College, Vellore, India
PRS Account Christian Medical College, Vellore, India
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP