NCT00269542

Brief Summary

Children, aged 1 months to 23 months, in the intervention households received zinc, iron and folic acid and those in the control households were administered iron and folic acid (IFA) alone for a period of one year. The primary outcomes were hospitalizations and deaths during this period.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
94,359

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2002

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

February 1, 2002

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
Last Updated

July 1, 2008

Status Verified

June 1, 2008

Enrollment Period

1.1 years

First QC Date

December 22, 2005

Last Update Submit

June 30, 2008

Conditions

MorbidityMortalityDiarrheaPneumonia

Keywords

zinc supplementationhospitalisationschildrenmortalityiron folic acid

Outcome Measures

Primary Outcomes (2)

  • - to determine the impact of daily oral supplementation of zinc (5 mg per day to infants aged less than 6 months and 10 mg per day to older children) and iron folic acid to children aged 1-23 months for a period of upto 12 months on all-cause mortality,

    3 monthly home visits

  • - to determine the impact of daily oral supplementation of zinc and iron folic acid to children 1-23 months for a period of upto 12 months on overall and diarrhea and pneumonia specific hospital admissions.

    3 monthly home visits

Secondary Outcomes (4)

  • - the proportion of stunted or underweight children at end study

    Baseline and end study after 12 months

  • - the proportion of zinc deficient (plasma zinc <60 mg/dl) children at end study

    Baseline and end study after 12 months

  • - the mean plasma copper and superoxide dismutase at end study

    Baseline and end study after 12 months

  • - the mean plasma ferritin and transferrin activity at end study

    Baseline and end study after 12 months

Study Arms (2)

1

EXPERIMENTAL
Drug: Zinc and iron folic acid - Intervention

2

PLACEBO COMPARATOR
Drug: Iron Folic Acid alone - Placebo

Interventions

Zinc and iron folic acid - InterventionDRUG

The intervention group tablet contained 10 mg of elemental zinc, 12.5 mg of iron and 50 micrograms of folic acid.

1
Iron Folic Acid alone - PlaceboDRUG

The control group tablets were similar in composition, appearance and taste except it contained placebo for zinc.

2

Eligibility Criteria

Age1 Month - 35 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age 1 months to 23 months
  • Either sex
  • Resident of study area

You may not qualify if:

  • Likely to leave the area during the study period
  • Non consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bhandari N, Taneja S, Mazumder S, Bahl R, Fontaine O, Bhan MK; Zinc Study Group. Adding zinc to supplemental iron and folic acid does not affect mortality and severe morbidity in young children. J Nutr. 2007 Jan;137(1):112-7. doi: 10.1093/jn/137.1.112.

    PMID: 17182810BACKGROUND

MeSH Terms

Conditions

DiarrheaPneumonia

Interventions

Zinc

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Maharaj K Bhan, MD

    Professor, Department of Pediatrics, All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Nita Bhandari, PhD

    Society for Applied Studies, New Delhi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2005

First Posted

December 23, 2005

Study Start

February 1, 2002

Primary Completion

March 1, 2003

Study Completion

August 1, 2003

Last Updated

July 1, 2008

Record last verified: 2008-06