Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months

NCT ID: NCT00269542

Last Updated: 2008-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94359 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2003-08-31

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.

Detailed Description

Objective: Studies in developing countries show substantial reduction in diarrhoea and respiratory morbidity in young children receiving zinc supplementation. The impact of daily zinc supplementation coadministered with iron folic acid in young children on all cause hospitalisation and mortality in comparison with iron folic acid alone, was evaluated to help shape public policy.

Design: Randomised double blind trial

Setting: Low to middle socio-economic urban neighbourhoods of north and north-west Delhi in India

Participants: 94359 subjects aged 1 month to 23 months

Interventions: The subjects were administered dispersible tablets containing one recommended daily allowance of zinc and iron folic acid or iron folic acid alone, daily for 12 months after enrolment.

Main outcome measures: Hospitalisations were captured through passive surveillance of eight hospitals by trained study physicians. Deaths were ascertained through bimonthly visits to households.

Results: A third of the total children had low zinc levels (<60 mg/dL) and one fourth had iron deficiency (haematocrit <33%) at baseline. The proportion zinc deficient was significantly lower post 12 months supplementation, in the zinc and iron folic acid group (difference in proportions -10%; 95% confidence interval -15.6% to -4.4%, p 0.0005). Only 7.7% in the zinc and iron folic acid and 7.3% in the iron folic acid group had low haematocrit. Zinc and iron folic acid supplementation had no impact on hospitalisations, overall and cause-specific. The overall death rates were similar in the two groups.

Conclusions: The lack of mortality impact may be real or the findings could have resulted from the use of lower daily zinc dosing than in morbidity prevention trials or an interaction between zinc and iron whereby adding iron, may have adversely affected potential effects of zinc on immune function and morbidity. Future research should address iron and zinc interaction effects on important functional outcomes.

Conditions

Morbidity; Mortality; Diarrhea; Pneumonia

Keywords

zinc supplementation; hospitalisations; children; mortality; iron folic acid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: EXPERIMENTAL

Zinc and iron folic acid - Intervention

Intervention Type: DRUG

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

2

Group Type: PLACEBO_COMPARATOR

Iron Folic Acid alone - Placebo

Intervention Type: DRUG

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

Interventions

Zinc and iron folic acid - Intervention

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

Intervention Type: DRUG

Iron Folic Acid alone - Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 35 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

World Health Organization

OTHER

Sponsor Role: collaborator

All India Institute of Medical Sciences

OTHER

Sponsor Role: collaborator

Society for Applied Studies

OTHER

Sponsor Role: lead

Responsible Party

All India Institute of Medical Sciences

Principal Investigators

Maharaj K Bhan, MD

Role: PRINCIPAL_INVESTIGATOR

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

Nita Bhandari, PhD

Role: PRINCIPAL_INVESTIGATOR

Society for Applied Studies, New Delhi

Countries

India

References

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.

Reference Type: BACKGROUND

PMID: 17182810 (View on PubMed)

Other Identifiers

C6-181-429

Identifier Type: -

Identifier Source: secondary_id

00002

Identifier Type: -

Identifier Source: org_study_id