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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Pulmonary Tuberculosis Drug: A. 100,000 IU Cholecalciferol per dose of 3.3ml Other: B. Migliol Oil without Cholecalciferol Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: A
Vitamin D in doses of 100,000 IU
 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
Placebo Comparator: B Other: B. Migliol Oil without Cholecalciferol
3.3 ml Migliol Oil, every two weeks for two months


Outcome Measures
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Primary Outcome Measures :
  1. Time to sputum culture conversion [ Time Frame: 8 weeks of treatment ]

Secondary Outcome Measures :
  1. Percent of Patients Culture Positive [ Time Frame: 8 Weeks ]
  2. Performance Status [ Time Frame: 8 Weeks ]
  3. Time To Sputum Smear Conversion [ Time Frame: Continous ]
  4. Proportion of Patients Smear Positive [ Time Frame: 4 Weeks, 8 Weeks, 12 Weeks ]
  5. Time To Growth In Liquid Media [ Time Frame: 8 Weeks ]
  6. RNTCP Treatment Outcomes [ Time Frame: 24 Weeks ]
  7. Weight Gain [ Time Frame: 8 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00366470


Locations
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India
Christian Medical College
Vellore, Tamil Nadu, India, 632004
Bethesda Hospital
Ambur, Tamilnadu, India, 635 802
Sponsors and Collaborators
Peter Daley
Dalhousie University
Investigators
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Principal Investigator: Dilip Mathai, MD, FCAMS Christian Medical College, Vellore, India
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Peter Daley, Lecturer, Christian Medical College, Vellore, India
ClinicalTrials.gov Identifier: NCT00366470     History of Changes
Other Study ID Numbers: TB-VitaminD
CTRI/2007/091/000008 ( Registry Identifier: Clinical Trials Registry of India )
First Posted: August 21, 2006    Key Record Dates
Last Update Posted: July 6, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Vitamins
 Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents