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

ISRCTN	ISRCTN85633178
DOI	https://doi.org/10.1186/ISRCTN85633178
ClinicalTrials.gov (NCT)	NCT00272142
Protocol serial number	WHO/HNI04002
Sponsor	The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Funder	The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)

Submission date: 08/02/2005
Registration date: 10/02/2005
Last edited: 15/07/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Olivier Fontaine
Scientific

World Health Organization
20, Avenue Appia
Geneva-27
CH 1211
Switzerland

Phone	+41 22 791 2894
Email	fontaineo@who.int

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Impact of zinc supplementation in low birth weight infants on severe morbidity and zinc status: a randomised controlled trial (India)
Study objectives	To determine the impact of daily oral supplementation of 1 Recommended Daily Allowance (RDA) of zinc in low birth weight infants on: 1. All causes hospitalisations, and 2. Illnesses requiring visit to health care providers
Ethics approval(s)	Ethics approval received from the World Health Organization (WHO) Ethical Review Committee on the 26th October 2005.
Health condition(s) or problem(s) studied	Low Birth Weight (LBW)
Intervention	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 per day for infants older than six months) daily for a period of one year compared to placebo (plain glucose) in the control group for a period of 12 months.
Intervention type	Supplement
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	10/09/2005

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	2000
Total final enrolment	2052
Key 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
Key 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
Date of first enrolment	10/09/2004
Date of final enrolment	10/09/2005

Locations

Countries of recruitment

India
Switzerland

Study participating centre

World Health Organization

Geneva-27
CH 1211
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/08/2009	15/07/2021	Yes	No

Editorial Notes

15/07/2021: ClinicalTrials.gov number, total final enrolment and publication reference added.