NCT00446758

Brief Summary

To examine whether daily oral zinc supplementation to HIV-infected Tanzanian preschool children reduces diarrheal and respiratory morbidity, delays HIV disease progression, and improves growth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
440

participants targeted

Target at P50-P75 for phase_3 hiv-infections

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_3 hiv-infections

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

First Submitted

Initial submission to the registry

March 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2007

Completed
12 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

September 14, 2012

Status Verified

September 1, 2012

Enrollment Period

1 year

First QC Date

March 12, 2007

Last Update Submit

September 13, 2012

Conditions

HIV Infections

Keywords

ZincHIVInfantsChildrenMorbidityChild health outcomestreatment naivetreatment experienced

Outcome Measures

Primary Outcomes (1)

  • Morbidity from respiratory and diarrheal infections, HIV disease progression

    every 4 to 6 months until the end of follow-up

Secondary Outcomes (1)

  • growth in height and weight

    every 4 to 6 months until the end of follow-up

Study Arms (2)

Zinc

EXPERIMENTAL

zinc (as zinc sulphate) 12.5 mg orally per day (6.25 mg in children \< 12 mo)

Dietary Supplement: Zinc

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Zinc

Interventions

ZincDIETARY_SUPPLEMENT

zinc effervescent tablets: 6.25mg to infants ≤12 months and 12.5 mg to children \> 12 months.

PlaceboZinc

Eligibility Criteria

Age6 Weeks - 60 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • HIV Infected Children under 60 months of age presenting at HIV treatment clinics in Dar es Salaam, Tanzania

You may not qualify if:

  • Eligible for ART: CD4 cell counts \< 20% or above pediatric clinical stage of HIV disease 3 according to WHO staging system.
  • Severe acute malnutrition; Major congenital malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhimbili University College of Health Sciences

Dar es Salaam, Tanzania

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Zinc

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Eduardo Villamor, 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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Associate Professor of International Nutrition

Study Record Dates

First Submitted

March 12, 2007

First Posted

March 13, 2007

Study Start

March 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

September 14, 2012

Record last verified: 2012-09

Locations

TA(1)