The impact of micronutrients and DHA on cognitive development of school-aged children: the NEMO studies.|
|- candidate number||1573|
|- NTR Number||NTR362|
|- Date ISRCTN created||19-dec-2005|
|- date ISRCTN requested||28-okt-2005|
|- Date Registered NTR||12-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||The impact of micronutrients and DHA on cognitive development of school-aged children: the NEMO studies.|
|- Scientific Title||The impact of micronutrients with or without DHA on cognitive development of school-aged children in Indonesia and South Australia. A randomized controlled trial.|
|- hypothesis||An 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) studied||Cognitive development|
|- Inclusion criteria||Children 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 criteria||In 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 received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2003|
|- planned closingdate||1-apr-2005|
|- Target number of participants||780|
|- Interventions||Children 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
|- Primary outcome||Cognitive performance (working memory, attention and concentration, perceptual speed, problem solving, executive function, learning and memory, school performance).|
|- Secondary outcome||Biochemical 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).
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| Jan Willem Klinken, van|
|- CONTACT for SCIENTIFIC QUERIES|| Saskia Osendarp |
|- Sponsor/Initiator ||Unilever Netherlands BV|
(Source(s) of Monetary or Material Support)
|- Publications||1. 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 summary||Background:|
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)|
|- RECORD||12-sep-2005 - 2-jul-2008|
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