Contact information
Type
Scientific
Primary contact
Miss Liandre van der Merwe
ORCID ID
Contact details
Medical Research Council International Nutrition Group
Nutrition and Public Health Intervention Research Unit
London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
Liandre.vanderMerwe@lshtm.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SCC1061
Study information
Scientific title
Acronym
IN3SS (Infant N-3 Supplementation Study)
Study hypothesis
Current hypotheses as of 12/01/2009:
Primary hypotheses:
1. Dietary n-3 long-chain polyunsaturated fatty acid (LCP) supplementation will improve rural African infants' growth performances
2. Dietary n-3 LCP supplementation will protect infant mucosal epithelial integrity
Secondary hypotheses:
1. Dietary n-3 LCP supplementation improves infant plasma n-3 fatty acid status
2. Dietary n-3 LCP supplementation will enhance the cognitive development of rural African infants
3. Dietary n-3 LCP supplementation will reduce the degree of intestinal inflammation of rural African infants
4. Dietary n-3 LCP supplementation will reduce infant systemic inflammation
5. Dietary n-3 LCP supplementation reduces incidence and severity of morbidities in rural African infants
Previous hypotheses:
Primary hypothesis:
Dietary long-chain n-3 polyunsaturated fatty acids (PUFA) supplementation may improve infant growth performance and head circumference (HC) measurements.
Secondary hypothesis:
Dietary long-chain n-3 PUFA supplementation may protect infant mucosal epithelial integrity and reduce mucosal inflammation.
Ethics approval
1. London School of Hygiene and Tropical Medicine Ethics Board, approved on 9 January 2007. Ref: 5072
2. Joint Medical Research Council Scientific Coordinating Committee/Gambian Government Ethics Committees, approved on 29 March 2007. Ref: SCC 1061
Study design
Randomised double-blind placebo-controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Infant growth and gut integrity
Intervention
Current interventions as of 12/01/2009:
The active group will receive 2 ml per day of highly purified fish oil (200 mg docosahexaenoic acid [DHA] and 300 mg eicosapentaenoic acid [EPA]) supplied by Nordic Naturals Inc, USA, for six months. The dosage was designed to achieve a substantial increase in plasma n-3 PUFA to both eliminate any existing deficiencies and to elicit a therapeutic response.
Previous interventions:
The active group will receive 2 ml per day of highly purified fish oil (500 mg docosahexaenoic acid [DHA] and 500 mg eicosapentaenoic acid [EPA]) supplied by Nordic Naturals Inc, USA, for six months. The dosage was designed to achieve a substantial increase in plasma n-3 PUFA to both eliminate any existing deficiencies and to elicit a therapeutic response.
Intervention type
Drug
Phase
Not Specified
Drug names
n-3 PolyUnsaturated Fatty Acids
Primary outcome measure
The following will be assessed at 3 and 9 months of age (i.e. at baseline and 6-month follow-up):
1. Infant anthropometric indicators
2. Gut permeability (dual sugar permeability test)
Secondary outcome measures
Current secondary outcome measures as of 12/01/2009:
1. Plasma fatty acid status (gas chromatography [GC])
2. Infant cognitive development (infant planning test and attention assessment)
3. Systemic inflammatory markers (a-acid glycoprotein [AGP], C-reactive protein [CRP] and plasma albumin)
4. Intestinal inflammation (faecal calprotectin)
5. Infant morbidities (daily morbidity assessments, clinic/nurse visits)
Measures 1, 3 and 4 will be measured at 3 and 9 months of age (i.e. at baseline and 6-month follow-up). Measure 2 will be measured at 12 months of age.
Previous secondary outcome measures:
The following secondary outcomes will also be measured at 3 and 9 months of age (i.e. at baseline and 6-month follow-up):
1. Plasma fatty acid status (gas chromatography [GC]) and systemic inflammatory markers (α-acid glycoprotein [AGP], C-reactive protein [CRP] and plasma albumin)
2. Intestinal inflammation (faecal neopterin and calprotectin)
Tertiary outcome measure: Daily morbidity assessments
Overall trial start date
02/04/2007
Overall trial end date
04/04/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Infants born in the larger villages of the West Kiang region of The Gambia
2. Aged 3 months
3. Not currently enrolled in any other study
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Severe congenital abnormalities that could affect growth and development
2. Known HIV infection
Added as of 12/01/2009:
3. Infants from multiple births
Recruitment start date
02/04/2007
Recruitment end date
04/04/2008
Locations
Countries of recruitment
Gambia
Trial participating centre
Medical Research Council International Nutrition Group
London
WC1E 7HT
United Kingdom
Sponsor information
Organisation
Medical Research Council (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
grants@headoffice.mrc.ac.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Funder name
Overseas Research Students Awards Scheme (ORSAS) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ernest Oppenheimer Memorial Trust (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
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23221579
Publication citations
-
Results
van der Merwe LF, Moore SE, Fulford AJ, Halliday KE, Drammeh S, Young S, Prentice AM, Long-chain PUFA supplementation in rural African infants: a randomized controlled trial of effects on gut integrity, growth, and cognitive development., Am. J. Clin. Nutr., 2013, 97, 1, 45-57, doi: 10.3945/ajcn.112.042267.