NCT00366470

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
3.2 years until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

July 6, 2012

Status Verified

July 1, 2012

Enrollment Period

2.5 years

First QC Date

August 18, 2006

Last Update Submit

July 4, 2012

Conditions

Pulmonary Tuberculosis

Outcome Measures

Primary Outcomes (1)

  • Time to sputum culture conversion

    8 weeks of treatment

Secondary Outcomes (7)

  • Percent of Patients Culture Positive

    8 Weeks

  • Performance Status

    8 Weeks

  • Time To Sputum Smear Conversion

    Continous

  • Proportion of Patients Smear Positive

    4 Weeks, 8 Weeks, 12 Weeks

  • Time To Growth In Liquid Media

    8 Weeks

  • +2 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Vitamin D in doses of 100,000 IU

Drug: A. 100,000 IU Cholecalciferol per dose of 3.3ml

B

PLACEBO COMPARATOR
Other: B. Migliol Oil without Cholecalciferol

Interventions

A. 100,000 IU Cholecalciferol per dose of 3.3mlDRUG

100,000 IU Cholecalciferol in 3.3ml Migliol (Carrier) oil, once every two weeks for 2 Months

A
B. Migliol Oil without CholecalciferolOTHER

3.3 ml Migliol Oil, every two weeks for two months

B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed smear positive pulmonary tuberculosis.
  • Age between 18 to 75 years
  • No pre-existing liver or renal disease
  • Available for return visits as outlined in the trial protocol
  • A Firm home address

You may not qualify if:

  • Extra-pulmonary or smear negative tuberculosis
  • Patients receiving steroids, cytotoxic drugs, post transplant or metastatic malignancy, or not expected to survive for the duration of ATT
  • Pregnant or lactating women
  • Active diarrhoea, indicating possible fat-soluble vitamin malabsorption.
  • Baseline Hypercalcemia \>10.5 mg/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bethesda Hospital

Ambur, Tamil Nadu, 635 802, India

Location

Christian Medical College

Vellore, Tamil Nadu, 632004, India

Location

Related Publications (1)

  • 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.

    PMID: 25863562DERIVED

Related Links

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Dilip Mathai, MD, FCAMS

    Christian Medical College, Vellore, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 18, 2006

First Posted

August 21, 2006

Study Start

November 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

July 6, 2012

Record last verified: 2012-07

Locations

IN(2)