NCT00057434

Brief Summary

The study will determine whether a daily vitamin and mineral supplement (a multivitamin including Vitamin A) will improve health when added to standard chemotherapy for tuberculosis. This study will compare the effectiveness of the multivitamin in HIV infected and HIV uninfected patients.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
1,140

participants targeted

Target at P75+ 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2003

Completed
Last Updated

September 18, 2007

Status Verified

August 1, 2007

First QC Date

April 1, 2003

Last Update Submit

September 17, 2007

Conditions

Pulmonary TuberculosisHIV Infections

Keywords

Vitamin A

Outcome Measures

Primary Outcomes (1)

  • Mortality

Secondary Outcomes (1)

  • Morbidity

Interventions

multivitaminDRUG

Eligibility Criteria

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

You may qualify if:

  • Sputum-confirmed pulmonary tuberculosis
  • Resident of Zomba or Blantyre Districts, Malawi
  • Willing to take tuberculosis chemotherapy as recommended by the National Tuberculosis Control Programme

You may not qualify if:

  • Prior treatment for tuberculosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zomba Central Hospital

Zomba, Malawi

Location

Related Publications (1)

  • Semba RD, Kumwenda J, Zijlstra E, Ricks MO, van Lettow M, Whalen C, Clark TD, Jorgensen L, Kohler J, Kumwenda N, Taha TE, Harries AD. Micronutrient supplements and mortality of HIV-infected adults with pulmonary TB: a controlled clinical trial. Int J Tuberc Lung Dis. 2007 Aug;11(8):854-9.

    PMID: 17705950DERIVED

MeSH Terms

Conditions

Tuberculosis, PulmonaryHIV Infections

Interventions

Geritol

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Richard D. Semba, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 1, 2003

First Posted

April 3, 2003

Study Start

September 1, 1998

Last Updated

September 18, 2007

Record last verified: 2007-08

Locations

MA(1)