The impact of micronutrients and docosahexaenoic acid (DHA) on cognitive development of school-aged children: the NEMO studies

ISRCTN ISRCTN75362637
DOI https://doi.org/10.1186/ISRCTN75362637
Secondary identifying numbers NTR362
Submission date
19/12/2005
Registration date
19/12/2005
Last edited
03/11/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jan Willem van Klinken
Scientific

Unilever Food and Health Research Institute (UFHRI)
P.O. Box 114
Vlaardingen
3130 AC
Netherlands

Email Jan-Willem-van.Klinken@Unilever.com

Study information

Study designMulticentre, randomised, double blind, placebo controlled, factorial trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleThe 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
Study acronymNEMO
Study objectivesAn 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(s)Received from the local medical ethics committee
Health condition(s) or problem(s) studiedCognitive development
InterventionChildren 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 typeSupplement
Primary outcome measureCognitive performance (working memory, attention and concentration, perceptual speed, problem solving, executive function, learning and memory, school performance)
Secondary outcome measures1. 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 study start date01/08/2003
Completion date01/04/2005

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Years
Upper age limit9 Years
SexBoth
Target number of participants780
Key inclusion criteria1. 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
Key exclusion criteriaIn 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)
Date of first enrolment01/08/2003
Date of final enrolment01/04/2005

Locations

Countries of recruitment

  • Australia
  • Indonesia
  • Netherlands

Study participating centre

Unilever Food and Health Research Institute (UFHRI)
Vlaardingen
3130 AC
Netherlands

Sponsor information

Unilever Nederlands BV (The Netherlands)
Industry

P.O. Box 160
Rotterdam
3000 AD
Netherlands

Website http://www.unilever.nl/
ROR logo "ROR" https://ror.org/02436cs38

Funders

Funder type

Not defined

Not provided at time of registration

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/10/2007 Yes No