Chilenje Infant Growth, Nutrition and Infection Study
ISRCTN | ISRCTN37460449 |
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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
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 design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Prevention |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | Prevalence of stunting |
Secondary outcome measures | 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 |
Overall study start date | 20/07/2005 |
Completion date | 30/06/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 6 Months |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
- Zambia
Study participating centre
Nutrition and Public Health Interventions Research Unit
London
WC1E 7HT
United Kingdom
WC1E 7HT
United Kingdom
Sponsor information
Bill and Melinda Gates Foundation (USA)
Charity
Charity
P.O. Box 23350
Seattle WA
98102
United States of America
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)
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |