Chilenje Infant Growth, Nutrition and Infection Study

ISRCTN	ISRCTN37460449
DOI	https://doi.org/10.1186/ISRCTN37460449
Protocol serial number	N/A
Sponsor	Bill and Melinda Gates Foundation (USA)
Funders	Bill and Melinda Gates Foundation (USA) - (ref: 37253), DSM (South Africa)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Suzanne Filteau
Scientific

Nutrition and Public Health Interventions Research Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Chilenje Infant Growth, Nutrition and Infection Study
Study acronym	CIGNIS
Study objectives	Feeding for 12 months with a fortified complementary food will decrease the proportion of stunted children by 30%.
Ethics approval(s)	Added 02/09/10: 1. Approved by the University of Zambia ethics committee 2. Approved by the London School of Hygiene and Tropical Medicine ethics committee
Health condition(s) or problem(s) studied	Infant growth faltering
Intervention	One of two locally developed complementary foods fed for 12 months
Intervention type	Other
Primary outcome measure(s)	Prevalence of stunting
Key secondary outcome measure(s)	1. Body composition 2. Indices of iron (Fe), zinc (Zn), copper (Cu), selenium (Se) and vitamin A status 3. Morbidity 4. Gastrointestinal permeability 5. Response to oral polio vaccine 6. Behavioural development 7. Development of chronic childhood viral infections
Completion date	30/06/2008

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Sex	All
Target sample size at registration	800
Key inclusion criteria	Infants aged 6 months and resident in Chilenje, Zambia whose mothers agree: 1. To prepare and feed their infants for 12 months the food supplied to them 2. To attend the specified clinic or home visits 3. To let their infants undergo specified urine collection and blood sampling 4. To permit the infants to be tested for human immunodeficiency virus (HIV)
Key exclusion criteria	Non-fulfilment of inclusion criteria or evidence of chronic disease (active tuberculosis [TB], symptomatic HIV)
Date of first enrolment	20/07/2005
Date of final enrolment	30/06/2008

Nutrition and Public Health Interventions Research Unit

London
WC1E 7HT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2011		Yes	No
Results article	results	01/02/2012		Yes	No
Results article	results	01/03/2012		Yes	No
Results article	results	01/11/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes