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
Secondary identifying numbers SCC1061
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

Study designRandomised double-blind placebo-controlled parallel-group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymIN3SS (Infant N-3 Supplementation Study)
Study objectivesCurrent 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) studiedInfant growth and gut integrity
InterventionCurrent 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)n-3 PolyUnsaturated Fatty Acids
Primary outcome measureThe 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 measuresCurrent 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 study start date02/04/2007
Completion date04/04/2008

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit3 Months
SexBoth
Target number of participants150
Key inclusion criteria1. 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 criteria1. 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 enrolment02/04/2007
Date of final enrolment04/04/2008

Locations

Countries of recruitment

  • England
  • Gambia
  • United Kingdom

Study participating centre

Medical Research Council International Nutrition Group
London
WC1E 7HT
United Kingdom

Sponsor information

Medical Research Council (UK)
Government

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email grants@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk
ROR logo "ROR" https://ror.org/03x94j517

Funders

Funder type

Government

Medical Research Council (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom
Overseas Research Students Awards Scheme (ORSAS) (UK)

No information available

Ernest Oppenheimer Memorial Trust (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 01/01/2013 Yes No