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Impact of zinc supplementation in low birth weight infants on severe morbidity and zinc status: a randomised controlled trial (India)

Impact of zinc supplementation in low birth weight infants on severe morbidity and zinc status: a randomised controlled trial (India)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN85633178
Enrollment
2000
Registered
2005-02-10
Start date
2004-09-10
Completion date
Unknown
Last updated
2021-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Birth Weight (LBW) Neonatal Diseases Low birth weight

Interventions

2000 infants in total: Infants in the intervention group will receive one Recommended Daily Allowance (RDA) of elemental zinc (5 mg elemental zinc per day in infants aged 14 days to 6 months and 10 mg

Sponsors

The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Infants aged 14 to 28 days born after 37 weeks of gestation and weighing less than or equal to 2.5 kg at birth (less than 10th percentile of the National Center for Health Statistics [NCHS] median birth weight) 2. Either sex 3. Resides within 7 km of the hospital

Exclusion criteria

Exclusion criteria: 1. Likely to leave the area of residence within six months of enrolment, i.e. visitors to the area, those that have already planned to visit their village, those definite that they are moving to another locality 2. Congenital malformations, congenital heart disease, metabolic disorders, renal diseases etc. 3. Non-consent for participation 4. Temporary exclusion criteria: illness requiring hospitalisation 5. Twins

Design outcomes

Primary

MeasureTime frame
1. Hospitalisations, measured at three monthly intervals 2. Healthcare provider visits, measured at three monthly intervals 3. Diarrhoea and Acute Respiratory Infection (ARI) morbidity, measured at three monthly intervals 4. Mortality, death identified at regular home visits 5. Proportion of stunted and under weight children, measured at three monthly visits 6. Plasma zinc, copper and iron, measured at baseline and end of study

Secondary

MeasureTime frame
Not provided at time of registration

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026