Friso MUM, the activity of a health supplement during pregnancy and lactation

ISRCTN ISRCTN58176213
DOI https://doi.org/10.1186/ISRCTN58176213
Secondary identifying numbers N/A
Submission date
19/12/2005
Registration date
19/12/2005
Last edited
07/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Saskia A van Goor
Scientific

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

Study information

Study designRandomised double-blind, placebo controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleThe 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
Study acronymMUM
Study objectivesDocosahexaenoic 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(s)Received from the local medical ethics committee
Health condition(s) or problem(s) studiedDevelopmental disorder
InterventionEverybody receives a multivitamin supplement (designed for pregnant women). As well as this we compare placebo versus DHA versus DHA/AA.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Docosahexaenoic acid (DHA), arachidonic acid (AA)
Primary outcome measureNeurological development of the baby (Neurological Optimality Score and General Movements)
Secondary outcome measures1. 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 study start date01/11/2004
Completion date01/10/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants300
Total final enrolment119
Key inclusion criteria1. Apparently healthy pregnant women
2. Para 0 or 1
3. Inclusion should take place prior to the 16th week of pregnancy
Key exclusion criteria1. 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
Date of first enrolment01/11/2004
Date of final enrolment01/10/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Center Groningen
Groningen
9700 RB
Netherlands

Sponsor information

Friesland Foods (The Netherlands)
Industry

PO Box 159
Ede
6710 BD
Netherlands

ROR logo https://ror.org/025mtxh67

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 01/02/2009 07/01/2021 Yes No

Editorial Notes

07/01/2021: Publication reference and total final enrolment added.

BMC - Part of Springer Nature Springer Nature