Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months
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|ClinicalTrials.gov Identifier: NCT00269542|
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : July 1, 2008
|Condition or disease||Intervention/treatment||Phase|
|Morbidity Mortality Diarrhea Pneumonia||Drug: Zinc and iron folic acid - Intervention Drug: Iron Folic Acid alone - Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94359 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months|
|Study Start Date :||February 2002|
|Actual Primary Completion Date :||March 2003|
|Actual Study Completion Date :||August 2003|
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.
- - 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 ]
- - 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 ]
- - the proportion of stunted or underweight children at end study [ Time Frame: Baseline and end study after 12 months ]
- - the proportion of zinc deficient (plasma zinc <60 mg/dl) children at end study [ Time Frame: Baseline and end study after 12 months ]
- - the mean plasma copper and superoxide dismutase at end study [ Time Frame: Baseline and end study after 12 months ]
- - the mean plasma ferritin and transferrin activity at end study [ Time Frame: Baseline and end study after 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00269542
|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|