| CTRI Number |
CTRI/2007/091/000008 [Registered on: 20/10/2009] |
| Last Modified On: |
23/06/2014 |
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of the addition of Vitamin D to conventional treatment in new pulmonary tuberculosis patients |
|
Scientific Title of Study
|
A double blind, randomized, parallel, placebo control design study to determine the effect of addition of Vitamin D to conventional anti TB therapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT00366470 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DrDilip Mathai |
| Designation |
|
| Affiliation |
|
| Address |
Infectious Diseases Training and Research Centre, Christian Medical College Vellore
Vellore
TAMIL NADU
632 004
India |
| Phone |
04162282804 |
| Fax |
04162211991 |
| Email |
dilipmathai@yahoo.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
DrPeter Daley |
| Designation |
|
| Affiliation |
Memorial University |
| Address |
Infectious Diseases Training & Research Centre, Christian Medical College Vellore
Vellore
TAMIL NADU
632 004
India |
| Phone |
04162282804 |
| Fax |
04162211991 |
| Email |
pkd336@mun.ca |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
DrDilip Mathai |
| Designation |
|
| Affiliation |
|
| Address |
Infectious Diseases Training and Research Centre
Christian Medical College
Vellore
TAMIL NADU
632 004
India |
| Phone |
04162282804 |
| Fax |
04162211991 |
| Email |
dilipmathai@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sponsored by Dalhousie University Internal Medicine Research Foundation, Halifax, Canada |
|
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Primary Sponsor
|
| Name |
Christian Medical College,Vellore |
| Address |
|
| Type of Sponsor |
|
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Dalhousie University, Canada |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Joel Nesaraj |
Bedestha Hospital |
,-632004
|
joelnesraj@rediffmail.com |
| Dr. KR JOHN |
CMC DOTS Centres |
Christian Medical College,IdaScudder Rd-632004
Vellore
TAMIL NADU |
mony@cmcvellore.ac.in |
| Dr. KR John |
CMC-CHAD Hospital |
Bagayam,Vellore-632004
Vellore
TAMIL NADU |
mony@cmcvellore.ac.in |
| Dr. KR JOHN |
TB Clinics Around Vellore |
Christian Medical College,Ida Scudder Road-632004
Vellore
TAMIL NADU |
mony@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| CMC-IRB to Bedestha Hospital |
Approved |
| CMC-IRB To CMC-CHAD Hospital |
Approved |
| CMC-IRB to TB clinical around Vellore |
Approved |
| Institutional Review Board (Ethics Committee) of CMC, Vellore |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
The study will be conducted in Newly Diagnosed Sputum Positive Pulmonary Tuberculosis patients., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Migliol oil containing Cholecalciferol |
100,000 IU cholecalciferol in 3.3ml carrier oil, once every two weeks for 2 months |
| Comparator Agent |
Migliol Oil without Cholecalciferol |
3.3ml identical carrier oil, every two weeks for two months |
|
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Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1. Newly diagnosed smear positive pulmonary tuberculosis, including previously treated
2. Age between 18 to 75 years
3. No pre-existing liver or renal disease
4. Consent given for HIV testing
5. Available for return visits as outlined in the trial protocol
6. A firm Home address
|
|
| ExclusionCriteria |
| Details |
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 infection
4.Pregnant or lactating women
5. Active diarrhoea, indicating possible fat-soluble vitamin malabsorption.
6.Baseline Hypercalcemia (>10.5 mg/dl)
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to sputum culture conversion |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
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Target Sample Size
|
Total Sample Size="250"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/11/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Under Review in Lancet Infectious Diseases |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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. |