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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN66645725

Enrollment

150

Registered

2007-05-31

Start date

2007-04-02

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant growth and gut integrity Nutritional, Metabolic, Endocrine

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 N

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 (a-acid glycoprotein [AGP], C-reactive protein [CRP] and plasma albumin) 2. Intestinal inflammation (faecal neopterin and calprotectin) Tertiary outcome measure: Daily morbidity assessments	—

Measure

Time frame

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 (a-acid glycoprotein [AGP], C-reactive protein [CRP] and plasma albumin) 2. Intestinal inflammation (faecal neopterin and calprotectin) Tertiary outcome measure: Daily morbidity assessments

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Countries

Gambia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 24, 2026