Chilenje Infant Growth, Nutrition and Infection Study

ISRCTN ISRCTN37460449
DOI https://doi.org/10.1186/ISRCTN37460449
Secondary identifying numbers N/A
Submission date
28/06/2005
Registration date
05/08/2005
Last edited
13/01/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleChilenje Infant Growth, Nutrition and Infection Study
Study acronymCIGNIS
Study objectivesFeeding 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) studiedInfant growth faltering
InterventionOne of two locally developed complementary foods fed for 12 months
Intervention typeOther
Primary outcome measurePrevalence of stunting
Secondary outcome measures1. 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
Overall study start date20/07/2005
Completion date30/06/2008

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Months
SexBoth
Target number of participants800
Key inclusion criteriaInfants 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 criteriaNon-fulfilment of inclusion criteria or evidence of chronic disease (active tuberculosis [TB], symptomatic HIV)
Date of first enrolment20/07/2005
Date of final enrolment30/06/2008

Locations

Countries of recruitment

  • England
  • United Kingdom
  • Zambia

Study participating centre

Nutrition and Public Health Interventions Research Unit
London
WC1E 7HT
United Kingdom

Sponsor information

Bill and Melinda Gates Foundation (USA)
Charity

P.O. Box 23350
Seattle WA
98102
United States of America

ROR logo "ROR" https://ror.org/0456r8d26

Funders

Funder type

Charity

Bill and Melinda Gates Foundation (USA) - (ref: 37253)
Government organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Bill & Melinda Gates Foundation, Gates Foundation, BMGF, B&MGF, GF
Location
United States of America
DSM (South Africa)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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