NCT01657656

Brief Summary

Hypothesis That improving vitamin D status among TB patients will speed the pace of bacteriological cure, and will enhance immune responses to TB infection

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

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 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 30, 2014

Status Verified

July 1, 2014

Enrollment Period

1.6 years

First QC Date

August 2, 2012

Last Update Submit

July 29, 2014

Conditions

Vitamin D SupplementsTuberculosisSputumCytokinesImmunity

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint will be time to sputum culture conversion from positive to negative.

    Eight weeks

Study Arms (2)

Vitamin D group

EXPERIMENTAL

Vitamin D supplement by Tishcon

Dietary Supplement: Vitamin D

Control group

PLACEBO COMPARATOR

Identically appearing capsules

Dietary Supplement: Vitamin D

Interventions

Vitamin DDIETARY_SUPPLEMENT
Control groupVitamin D group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sputum positive TB patients

You may not qualify if:

  • We will exclude those with abnormal LFTs at baseline (2.5 times upper limit of normal), as they will be at higher risk of developing drug-induced hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Center for Communicable Dieases

Ulaanbaatar, Mongolia

Location

Related Publications (1)

  • Ganmaa D, Munkhzul B, Fawzi W, Spiegelman D, Willett WC, Bayasgalan P, Baasansuren E, Buyankhishig B, Oyun-Erdene S, Jolliffe DA, Xenakis T, Bromage S, Bloom BR, Martineau AR. High-Dose Vitamin D3 during Tuberculosis Treatment in Mongolia. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2017 Sep 1;196(5):628-637. doi: 10.1164/rccm.201705-0936OC.

    PMID: 28692301DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 6, 2012

Study Start

October 1, 2012

Primary Completion

May 1, 2014

Study Completion

July 1, 2014

Last Updated

July 30, 2014

Record last verified: 2014-07

Locations

MO(1)