Welcome
Support Centre
02 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Long-chain n-3 polyunsaturated fatty acids in relation to gut integrity, growth failure and cognitive development of rural African infants
ISRCTN ISRCTN66645725
DOI 10.1186/ISRCTN66645725
ClinicalTrials.gov identifier
EudraCT number
Public title Long-chain n-3 polyunsaturated fatty acids in relation to gut integrity, growth failure and cognitive development of rural African infants
Scientific title
Acronym IN3SS (Infant N-3 Supplementation Study)
Serial number at source SCC1061
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.
Lay summary Not provided at time of registration
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
Countries of recruitment Gambia
Disease/condition/study domain Infant growth and gut integrity
Participants - 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
Participants - 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
Anticipated start date 02/04/2007
Anticipated end date 04/04/2008
Status of trial Completed
Patient information material
Target number of participants 150
Interventions 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.
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)
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
Sources of funding 1. Medical Research Council (UK)
2. Overseas Research Students Awards Scheme (ORSAS) (UK)
3. Ernest Oppenheimer Memorial Trust (South Africa)
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23221579
Contact name Miss  Liandre  van der Merwe
  Address Medical Research Council International Nutrition Group
Nutrition and Public Health Intervention Research Unit
London School of Hygiene & Tropical Medicine
Keppel Street
  City/town London
  Zip/Postcode WC1E 7HT
  Country United Kingdom
  Email Liandre.vanderMerwe@lshtm.ac.uk
Sponsor Medical Research Council (UK)
  Address 20 Park Crescent
  City/town London
  Zip/Postcode W1B 1AL
  Country United Kingdom
  Tel +44 (0)20 7636 5422
  Email grants@headoffice.mrc.ac.uk
  Sponsor website: http://www.mrc.ac.uk
Date applied 14/03/2007
Last edited 12/12/2012
Date ISRCTN assigned 31/05/2007
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.