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Chilenje Infant Growth, Nutrition and Infection Study
DOI 10.1186/ISRCTN37460449
ClinicalTrials.gov identifier
EudraCT number
Public title Chilenje Infant Growth, Nutrition and Infection Study
Scientific title
Acronym CIGNIS
Serial number at source N/A
Study hypothesis Feeding for 12 months with a fortified complementary food will decrease the proportion of stunted children by 30%.
Lay summary Not provided at time of registration
Ethics approval 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
Study design Randomised controlled trial
Countries of recruitment Zambia
Disease/condition/study domain Infant growth faltering
Participants - 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)
Participants - exclusion criteria Non-fulfilment of inclusion criteria or evidence of chronic disease (active tuberculosis [TB], symptomatic HIV)
Anticipated start date 20/07/2005
Anticipated end date 30/06/2008
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 800
Interventions One of two locally developed complementary foods fed for 12 months
Primary outcome measure(s) Prevalence of stunting
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
Sources of funding 1. Bill and Melinda Gates Foundation (USA) - (ref: 37253)
2. DSM (South Africa)
Trial website
Publications 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21411608
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21733297
3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21899803
Contact name Dr  Suzanne  Filteau
  Address Nutrition and Public Health Interventions Research Unit
London School of Hygiene and Tropical Medicine
Keppel Street
  City/town London
  Zip/Postcode WC1E 7HT
  Country United Kingdom
Sponsor Bill and Melinda Gates Foundation (USA)
  Address P.O. Box 23350
  City/town Seattle WA
  Zip/Postcode 98102
  Country United States of America
Date applied 28/06/2005
Last edited 18/04/2012
Date ISRCTN assigned 05/08/2005
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