Long-chain n-3 polyunsaturated fatty acids in relation to gut integrity, growth failure and cognitive development of rural African infants
ISRCTN | ISRCTN66645725 |
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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
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
Liandre.vanderMerwe@lshtm.ac.uk |
Study information
Study design | Randomised double-blind placebo-controlled parallel-group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | 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 study start date | 02/04/2007 |
Completion date | 04/04/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 3 Months |
Sex | Both |
Target number of participants | 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
- England
- Gambia
- United Kingdom
Study participating centre
Medical Research Council International Nutrition Group
London
WC1E 7HT
United Kingdom
WC1E 7HT
United Kingdom
Sponsor information
Medical Research Council (UK)
Government
Government
20 Park Crescent
London
W1B 1AL
United Kingdom
Phone | +44 (0)20 7636 5422 |
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grants@headoffice.mrc.ac.uk | |
Website | http://www.mrc.ac.uk |
https://ror.org/03x94j517 |
Funders
Funder type
Government
Medical Research Council (UK)
Government organisation / National government
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/01/2013 | Yes | No |