NCT00197704

Brief Summary

The purpose of this study is to determine the efficacy of micronutrient supplementation among patients with active tuberculosis, half of who are co-infected with HIV-1

Trial Health

87
On Track

Trial Health Score

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

Enrollment
876

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2000

Typical duration for phase_3

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

Study Start

First participant enrolled

March 1, 2000

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

November 11, 2010

Status Verified

November 1, 2010

Enrollment Period

4.2 years

First QC Date

September 12, 2005

Last Update Submit

November 9, 2010

Conditions

Tuberculosis

Keywords

TuberculosisHIVTanzaniamultivitamins

Outcome Measures

Primary Outcomes (1)

  • To determine the efficacy of micronutrient supplements on sputum conversion, survival, and TB relapse and reinfection.

    Sputum and culture negativity: 1 month and 2 months; Survival: 8 months and 24 months; TB relapse and reinfection: throughout follow-up.

Secondary Outcomes (1)

  • To examine the effect of micronutrient supplements on HIV viral load, CD4 counts, body weight and immunological parameters.

    Rate of change of HIV viral load in HIV positive patients: 2, 5, 8, and 20 months; Absolute change in CD4 counts: 2, 5, 8, and 20 months; Weight change from baseline: 2, 8, and 20 months; Immunological parameters: 2, 8, and 20 months.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Multivitamins

EXPERIMENTAL

5000 IU of retinol, 20 mg of B1, 20 mg of B2, 25 mg of B6, 100 mg of niacin, 50 mcg of B12, 500 of C, 200 mg of E, 0.8 mg of folic acid, and 100 mcg of selenium

Dietary Supplement: Multivitamins

Interventions

MultivitaminsDIETARY_SUPPLEMENT

5000 IU of retinol, 20 mg of B1, 20 mg of B2, 25 mg of B6, 100 mg of niacin, 50 mcg of B12, 500 of C, 200 mg of E, 0.8 mg of folic acid, and 100 mcg of selenium taken orally on a daily basis from the start of TB therapy through 8 months of anti-TB therapy

Multivitamins
PlaceboOTHER

Placebo pill taken orally on a daily basis from the start of TB therapy through 8 months of anti-TB therapy

Placebo

Eligibility Criteria

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

You may qualify if:

  • Men and women, age 18 to 60 years inclusive
  • At least two positive sputum smears for tuberculosis
  • Intention to stay in Dar-es-Salaam for at least 2 years after the start of TB therapy
  • Subjects who grant informed consent to participation

You may not qualify if:

  • Karnofsky score \< 40%
  • Hemoglobin \< 8.5 g/dl
  • Having had treatment for TB exceeding 4 weeks in the last 5 years
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard School of Public Health

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

  • Villamor E, Mugusi F, Urassa W, Bosch RJ, Saathoff E, Matsumoto K, Meydani SN, Fawzi WW. A trial of the effect of micronutrient supplementation on treatment outcome, T cell counts, morbidity, and mortality in adults with pulmonary tuberculosis. J Infect Dis. 2008 Jun 1;197(11):1499-505. doi: 10.1086/587846.

    PMID: 18471061RESULT

  • Mehta S, Mugusi FM, Bosch RJ, Aboud S, Urassa W, Villamor E, Fawzi WW. Vitamin D status and TB treatment outcomes in adult patients in Tanzania: a cohort study. BMJ Open. 2013 Nov 18;3(11):e003703. doi: 10.1136/bmjopen-2013-003703.

    PMID: 24247327DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Geritol

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Wafaie W Fawzi, MD,DrPh

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

March 1, 2000

Primary Completion

May 1, 2004

Study Completion

May 1, 2004

Last Updated

November 11, 2010

Record last verified: 2010-11

Locations

US(1)