Friso MUM, the activity of a health supplement during pregnancy and lactation
| ISRCTN | ISRCTN58176213 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58176213 |
| Protocol serial number | N/A |
| Sponsor | Friesland Foods (The Netherlands) |
| Funder | Not provided at time of registration |
- 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
Scientific
University Medical Center Groningen
Department of Pathology and Laboratory Medicine
Postblok CMC-V-1 floor
P.O. Box 30001
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50 3610399 |
|---|---|
| s.a.van.goor@lc.umcg.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind, placebo controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Study acronym | MUM |
| Study objectives | 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(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Docosahexaenoic acid (DHA), arachidonic acid (AA) |
| Primary outcome measure(s) |
Neurological development of the baby (Neurological Optimality Score and General Movements) |
| Key secondary outcome measure(s) |
1. Mood, cognitive functioning and sleeping rhythm of the mother |
| Completion date | 01/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 300 |
| Total final enrolment | 119 |
| Key inclusion criteria | 1. Apparently healthy pregnant women 2. Para 0 or 1 3. Inclusion should take place prior to the 16th week of pregnancy |
| Key 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 |
| Date of first enrolment | 01/11/2004 |
| Date of final enrolment | 01/10/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Groningen
Groningen
9700 RB
Netherlands
9700 RB
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 | 01/02/2009 | 07/01/2021 | Yes | No |
Editorial Notes
07/01/2021: Publication reference and total final enrolment added.
