Trial of Zinc and HIV Progression in Children | NCT00446758

Studies
Trial of Zinc and HIV Progression in Children

NCT00446758

Sponsor

Harvard School of Public Health (HSPH)

Status

Completed

Last Update Posted

Sep 14, 2012Estimated

Enrollment

440Actual

Phase

Phase 3

Conditions

HIV Infections

Interventions

Zinc

Countries

Tanzania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Mar 12, 2007

First Submission Date that Met QC Criteria

Mar 12, 2007

First Posted Date

Mar 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2012

Last Update Posted Date

Sep 14, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eduardo Villamor, Adjunct Associate Professor of International Nutrition, Harvard School of Public Health (HSPH)Principal Investigator

Lead Sponsor

Harvard School of Public Health (HSPH)OTHER

Collaborators

Name	Class
Thrasher Research Fund	OTHER
Muhimbili University of Health and Allied Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The purpose of this study is 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

440Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Zinc	Dietary Supplement	zinc effervescent tablets: 6.25mg to infants ≤12 months and 12.5 mg to children > 12 months.	Placebo Zinc

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Morbidity from respiratory and diarrheal infections, HIV disease progression		every 4 to 6 months until the end of follow-up

Secondary Outcomes

Measure	Description	Time Frame
growth in height and weight		every 4 to 6 months until the end of follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Weeks

Maximum Age

60 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eduardo Villamor, MD, DrPH	Harvard School of Public Health (HSPH)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Muhimbili University College of Health Sciences		Dar es Salaam			Tanzania

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015032	Zinc

Ancestor Terms

ID	Term
D019216	Metals, Heavy
D004602	Elements
D007287	Inorganic Chemicals
D028561	Transition Elements

Browse Leaves

Not provided

Browse Branches

Not provided