Condition category
Neonatal Diseases
Date applied
08/02/2005
Date assigned
10/02/2005
Last edited
17/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Olivier Fontaine

ORCID ID

Contact details

World Health Organization
20
Avenue Appia
Geneva-27
CH 1211
Switzerland
+41 22 791 2894
fontaineo@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WHO/HNI04002

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval received from the World Health Organization (WHO) Ethical Review Committee on the 26th October 2005.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Zinc supplementation

Primary outcome measures

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 outcome measures

Not provided at time of registration

Overall trial start date

10/09/2004

Overall trial end date

10/09/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

2000

Participant 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

Recruitment start date

10/09/2004

Recruitment end date

10/09/2005

Locations

Countries of recruitment

India

Trial participating centre

World Health Organization
Geneva-27
CH 1211
Switzerland

Sponsor information

Organisation

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

Sponsor details

20
Avenue Appia
Geneva-27
CH 1211
Switzerland

Sponsor type

Research organisation

Website

http://www.who.int

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes