Condition category
Mental and Behavioural Disorders
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
23/10/2008
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 Saskia A van Goor

ORCID ID

Contact details

University Medical Center Groningen
Department of Pathology and Laboratory Medicine
Postblok CMC-V-1 floor
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 3610399
s.a.van.goor@lc.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of high docosahexaenoic acid (DHA)-fish oil and arachidonic acid (AA) suppletion during pregnancy and lactation on long-chain polyunsaturated fatty acids (LCP) status of mother and child and on the neurological development of the baby

Acronym

MUM

Study hypothesis

Docosahexaenoic acid (DHA) and arachidonic acid (AA) during pregnancy shall lead to a better neurological development of the baby and possibly to better mood, cognitive functioning and sleeping rhythm of the mother.

Ethics approval

Received from the local medical ethics committee

Study design

Randomised double-blind, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Developmental disorder

Intervention

Everybody receives a multivitamin supplement (designed for pregnant women). As well as this we compare placebo versus DHA versus DHA/AA.

Intervention type

Drug

Phase

Not Specified

Drug names

Docosahexaenoic acid (DHA), arachidonic acid (AA)

Primary outcome measures

Neurological development of the baby (Neurological Optimality Score and General Movements)

Secondary outcome measures

1. Mood, cognitive functioning and sleeping rhythm of the mother
2. LCP status in red blood cells of mother (16th and 36th week) and child (12 weeks after birth), umbilical cord, breast milk (2 and 12 weeks after birth)

Overall trial start date

01/11/2004

Overall trial end date

01/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Apparently healthy pregnant women
2. Para 0 or 1
3. Inclusion should take place prior to the 16th week of pregnancy

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

300

Participant exclusion criteria

1. Hyperemesis Gravidarum
2. Vegetarian or vegan
3. Pregnant with twins
4. Diabetes Mellitus type 1
5. Usage of health supplements with fatty acids, tryptophan or melatonin

Recruitment start date

01/11/2004

Recruitment end date

01/10/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

Friesland Foods (The Netherlands)

Sponsor details

P.O. Box 159
Ede
6710 BD
Netherlands

Sponsor type

Not defined

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes