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van CCT (UK)

van CCT (UK)

The impact of micronutrients and DHA on cognitive development of school-aged children: the NEMO studies.

- candidate number1573
- NTR NumberNTR362
- Date ISRCTN created19-dec-2005
- date ISRCTN requested28-okt-2005
- Date Registered NTR12-sep-2005
- Secondary IDsN/A 
- Public TitleThe impact of micronutrients and DHA on cognitive development of school-aged children: the NEMO studies.
- Scientific TitleThe impact of micronutrients with or without DHA on cognitive development of school-aged children in Indonesia and South Australia. A randomized controlled trial.
- hypothesisAn intervention with a fortified drink containing iron, zinc, vitamin A, vitamin C, folate, vitamin B-12 and B-6 and/or omega-3 polyunsaturated fatty acids over one year can improve cognitive performance in Australian well-nourished children and Indonesian marginally-nourished children.
- Healt Condition(s) or Problem(s) studiedCognitive development
- Inclusion criteriaChildren aged 6-9 yrs of age from six selected schools in urban Jakarta and 42 public schools in Southern Australia Parents or carers provided informed consent.
- Exclusion criteriaIn the two study site:
Children with severe physical and neurological health problems.
No (intended) use of micronutrient/mineral and/or fatty acid supplements.
In addition in Indonesia excluded are: children who are severely malnourished (Wt/Ht Z-score <=- 3SD) or severely anemic (hemoglobin < 8 g/L).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2003
- planned closingdate1-apr-2005
- Target number of participants780
- InterventionsChildren receiving fortified drink containing either:

Micronutrient mix (iron, vit A, vit C, Vit B12, Vit B6 at one RDA, zinc at half RDA)
or 88 mg DHA and 22 mg EPA
or both
or placebo
- Primary outcomeCognitive performance (working memory, attention and concentration, perceptual speed, problem solving, executive function, learning and memory, school performance).
- Secondary outcomeBiochemical indicators (blood iron status, zinc status, folate, vitamin B12)
Fatty acids status (plasma EPA, DPA, DHA, ALA and total n-3 plasma mass)
Growth (weight, height, body mass index).
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Jan Willem Klinken, van
- Sponsor/Initiator Unilever Netherlands BV
- Funding
(Source(s) of Monetary or Material Support)
- Publications1. Am J Clin Nutr. 2007 Oct;86(4):1082-93.

2. The impact of micronutrients and DHA on cognitive development of school-aged children: the NEMO-studies.
The NEMO Study Group (W Lukito1, S Osendarp2, C Wilson3)
1 SEAMEO-TROPMED, RCCN, University of Indonesia, Jakarta, Indonesia
2 Unilever Health Institute, Vlaardingen, The Netherlands
3 CSIRO, Health Sciences and Nutrition, Adelaide, Australia
(Accepted for presentation at IUNS conference, Sept 19, Durban, South Africa)
- Brief summaryBackground:
Micronutrients and essential fatty acids, notably DHA and EPA, have been shown to improve cognitive performance in infants and young children.
However, evidence on the effect of supplementation with micronutrients, DHA or both on cognitive development in school-aged children is not available.

A two-by-two factorial randomized, controlled, double-blind trial was undertaken to assess the effect of micronutrients, DHA or both on indicators of cognitive performance in school-aged children in an urban poor area of Jakarta, Indonesia.

382 children (6-10 yr) were randomly allocated to receive a drink with either a micronutrient mix (iron, zinc, vitamin A, folate, vitamin B6, B12 and C at one RDA), or DHA (88 mg/d) + EPA (22 mg/d), or both or placebo 6 days/week, for 12 months.
In addition in Indonesia all four groups receive protein-energy supplement (non-fortified biscuits). Iron status, zinc status, folate, vitamin B12, and n-3 fatty acids were determined at baseline and 12 months.
Cognitive performance was measured at baseline, 6 and 12 months using a set of tests to assess attention and concentration, memory and learning, speed of information processing, executive functions and school performance.

Preliminary findings indicate that there was a strong main effect of micronutrients on improvement in serum ferritin, serum transferrin receptor, folate, and vitamin B12, and of both micronutrients and DHA on plasma DHA and total n-3 fatty acids. The impact of the intervention on cognitive performance is currently being investigated and results will be presented at the meeting.
- Main changes (audit trail)
- RECORD12-sep-2005 - 2-jul-2008

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