Long-chain n-3 polyunsaturated fatty acids in relation to gut integrity, growth failure and cognitive development of rural African infants

ISRCTN	ISRCTN66645725
DOI	https://doi.org/10.1186/ISRCTN66645725
Protocol serial number	SCC1061
Sponsor	Medical Research Council (UK)
Funders	Medical Research Council (UK), Overseas Research Students Awards Scheme (ORSAS) (UK), Ernest Oppenheimer Memorial Trust (South Africa)

Submission date: 14/03/2007
Registration date: 31/05/2007
Last edited: 12/12/2012

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

Miss Liandre van der Merwe
Scientific

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

Email	Liandre.vanderMerwe@lshtm.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled parallel-group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	IN3SS (Infant N-3 Supplementation Study)
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	n-3 PolyUnsaturated Fatty Acids
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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
Completion date	04/04/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Months
Sex	All
Target sample size at registration	150
Key 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
Key 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
Date of first enrolment	02/04/2007
Date of final enrolment	04/04/2008

Locations

Countries of recruitment

United Kingdom
England
Gambia

Study participating centre

Medical Research Council International Nutrition Group

London
WC1E 7HT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/01/2013		Yes	No