Condition category
Nervous System Diseases
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
03/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.unilever.nl/

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/17921387

Publication citations

  1. 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.

Additional files

Editorial Notes