Contact information
Type
Scientific
Primary contact
Dr Jan Willem van Klinken
ORCID ID
Contact details
Unilever Food and Health Research Institute (UFHRI)
P.O. Box 114
Vlaardingen
3130 AC
Netherlands
Jan-Willem-van.Klinken@Unilever.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR362
Study information
Scientific title
The impact of micronutrients with or without docosahexaenoic acid (DHA) on cognitive development of school-aged children in Indonesia and South Australia: a randomised controlled trial
Acronym
NEMO
Study 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.
Ethics approval
Received from the local medical ethics committee
Study design
Multicentre, randomised, double blind, placebo controlled, factorial trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Cognitive development
Intervention
Children receiving fortified drink containing either:
1. Micronutrient mix (iron, vitamin A, vitamin C, vitamin B12, vitamin B6 at one recommended daily allowance [RDA], zinc at half RDA)
2. 88 mg DHA and 22 mg EPA
3. Both
4. Placebo
Intervention type
Supplement
Phase
Not Specified
Drug names
Iron, zinc, vitamin A, vitamin C, folate, vitamin B-12 and B-6 and/or omega-3 polyunsaturated fatty acids
Primary outcome measure
Cognitive performance (working memory, attention and concentration, perceptual speed, problem solving, executive function, learning and memory, school performance)
Secondary outcome measures
1. Biochemical indicators (blood iron status, zinc status, folate, vitamin B12)
2. Fatty acids status (plasma EPA, DPA, DHA, ALA and total n-3 plasma mass)
3. Growth (weight, height, body mass index)
Overall trial start date
01/08/2003
Overall trial end date
01/04/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children aged 6-9 years of age from six selected schools in urban Jakarta and 42 public schools in Southern Australia
2. Parents or carers provided informed consent
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
780
Participant exclusion criteria
In the two study sites:
1. Children with severe physical and neurological health problems
2. No (intended) use of micronutrient/mineral and/or fatty acid supplements
In addition in Indonesia:
3. Children who are severely malnourished (weight/height Z-score less than or equal to -3 standard deviation [SD]) or severely anaemic (haemoglobin less than 8 g/l)
Recruitment start date
01/08/2003
Recruitment end date
01/04/2005
Locations
Countries of recruitment
Australia, Indonesia
Trial participating centre
Unilever Food and Health Research Institute (UFHRI)
Vlaardingen
3130 AC
Netherlands
Sponsor information
Organisation
Unilever Nederlands BV (The Netherlands)
Sponsor details
P.O. Box 160
Rotterdam
3000 AD
Netherlands
Sponsor type
Industry
Website
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/17921387
Publication citations
-
Results
Osendarp SJ, Baghurst KI, Bryan J, Calvaresi E, Hughes D, Hussaini M, Karyadi SJ, van Klinken BJ, van der Knaap HC, Lukito W, Mikarsa W, Transler C, Wilson C, , Effect of a 12-mo micronutrient intervention on learning and memory in well-nourished and marginally nourished school-aged children: 2 parallel, randomized, placebo-controlled studies in Australia and Indonesia., Am. J. Clin. Nutr., 2007, 86, 4, 1082-1093.