Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/06/2005
Date assigned
05/08/2005
Last edited
13/01/2015
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 Suzanne Filteau

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Chilenje Infant Growth, Nutrition and Infection Study

Acronym

CIGNIS

Study hypothesis

Feeding for 12 months with a fortified complementary food will decrease the proportion of stunted children by 30%.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Infant growth faltering

Intervention

One of two locally developed complementary foods fed for 12 months

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

20/07/2005

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

800

Participant exclusion criteria

Non-fulfilment of inclusion criteria or evidence of chronic disease (active tuberculosis [TB], symptomatic HIV)

Recruitment start date

20/07/2005

Recruitment end date

30/06/2008

Locations

Countries of recruitment

Zambia

Trial participating centre

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

Sponsor information

Organisation

Bill and Melinda Gates Foundation (USA)

Sponsor details

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

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

Bill and Melinda Gates Foundation (USA) - (ref: 37253)

Alternative name(s)

Bill & Melinda Gates Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Funder name

DSM (South Africa)

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

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
4. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25332481

Publication citations

  1. Results

    Gibson RS, Kafwembe E, Mwanza S, Gosset L, Bailey KB, Mullen A, Baisley K, Filteau S, A micronutrient-fortified food enhances iron and selenium status of Zambian infants but has limited efficacy on zinc., J. Nutr., 2011, 141, 5, 935-943, doi: 10.3945/jn.110.135228.

  2. Results

    Manno D, Kowa PK, Bwalya HK, Siame J, Grantham-McGregor S, Baisley K, De Stavola BL, Jaffar S, Filteau S, Rich micronutrient fortification of locally produced infant food does not improve mental and motor development of Zambian infants: a randomised controlled trial., Br. J. Nutr., 2012, 107, 4, 556-566, doi: 10.1017/S0007114511003217.

  3. Results

    Mullen A, Gosset L, Larke N, Manno D, Chisenga M, Kasonka L, Filteau S, The effects of micronutrient-fortified complementary/replacement food on intestinal permeability and systemic markers of inflammation among maternally HIV-exposed and unexposed Zambian infants., Br. J. Nutr., 2012, 107, 6, 893-902, doi: 10.1017/S0007114511003734.

  4. Results

    Mallard SR, Houghton LA, Filteau S, Mullen A, Nieuwelink J, Chisenga M, Siame J, Gibson RS, Dietary diversity at 6 months of age is associated with subsequent growth and mediates the effect of maternal education on infant growth in urban Zambia, J Nutr, 2014, 144, 11, 1818-1825, doi: 10.3945/jn.114.199547.

Additional files

Editorial Notes