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

This study has been completed.
Sponsor:
Collaborators:
World Health Organization
All India Institute of Medical Sciences, New Delhi
Information provided by:
Society for Applied Studies
ClinicalTrials.gov Identifier:
NCT00269542
First received: December 22, 2005
Last updated: June 30, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention
Morbidity
Mortality
Diarrhea
Pneumonia
Drug: Zinc and iron folic acid - Intervention
Drug: Iron Folic Acid alone - Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months

Resource links provided by NLM:


Further study details as provided by Society for Applied Studies:

Primary Outcome Measures:
  • - 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, [ Time Frame: 3 monthly home visits ] [ Designated as safety issue: No ]
  • - 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. [ Time Frame: 3 monthly home visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - the proportion of stunted or underweight children at end study [ Time Frame: Baseline and end study after 12 months ] [ Designated as safety issue: No ]
  • - the proportion of zinc deficient (plasma zinc <60 mg/dl) children at end study [ Time Frame: Baseline and end study after 12 months ] [ Designated as safety issue: No ]
  • - the mean plasma copper and superoxide dismutase at end study [ Time Frame: Baseline and end study after 12 months ] [ Designated as safety issue: No ]
  • - the mean plasma ferritin and transferrin activity at end study [ Time Frame: Baseline and end study after 12 months ] [ Designated as safety issue: No ]

Enrollment: 94359
Study Start Date: February 2002
Study Completion Date: August 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: 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.
Placebo Comparator: 2 Drug: Iron Folic Acid alone - Placebo
The control group tablets were similar in composition, appearance and taste except it contained placebo for zinc.

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.

  Eligibility

Ages Eligible for Study:   1 Month to 35 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  • Temporary exclusion criteria Illness requiring hospitalization Visible severe wasting. Visibly wasted children will be referred to a hospital for treatment. They will be eligible for enrollment only after effective rehabilitation.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00269542

Sponsors and Collaborators
Society for Applied Studies
World Health Organization
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: 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
  More Information

Publications:
Responsible Party: Dr. MK Bhan, All India Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT00269542     History of Changes
Other Study ID Numbers: 00002, C6-181-429
Study First Received: December 22, 2005
Last Updated: June 30, 2008
Health Authority: India: Ministry of Health

Keywords provided by Society for Applied Studies:
zinc supplementation
hospitalisations
children
mortality
iron folic acid

Additional relevant MeSH terms:
Iron
Zinc
Folic Acid
Vitamin B Complex
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses
Vitamins

ClinicalTrials.gov processed this record on October 16, 2014