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 |
| Protocol serial number | NTR362 |
| Sponsor | Unilever Nederlands BV (The Netherlands) |
| Funder | Not provided at time of registration |
- 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
Scientific
Unilever Food and Health Research Institute (UFHRI)
P.O. Box 114
Vlaardingen
3130 AC
Netherlands
| Jan-Willem-van.Klinken@Unilever.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, double blind, placebo controlled, factorial trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Study acronym | NEMO |
| Study objectives | 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(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Cognitive performance (working memory, attention and concentration, perceptual speed, problem solving, executive function, learning and memory, school performance) |
| Key secondary outcome measure(s) |
1. Biochemical indicators (blood iron status, zinc status, folate, vitamin B12) |
| Completion date | 01/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 9 Years |
| Sex | All |
| Target sample size at registration | 780 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/08/2003 |
| Date of final enrolment | 01/04/2005 |
Locations
Countries of recruitment
- Australia
- Indonesia
- Netherlands
Study participating centre
Unilever Food and Health Research Institute (UFHRI)
Vlaardingen
3130 AC
Netherlands
3130 AC
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
