Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/03/2007
Date assigned
31/05/2007
Last edited
12/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.mrc.ac.uk

Funders

Funder type

Government

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23221579

Publication citations

  1. 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.

Additional files

Editorial Notes