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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN58176213 |
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Date of registration:
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19/12/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Friso MUM, the activity of a health supplement during pregnancy and lactation
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Scientific title:
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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 |
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Date of first enrolment:
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01/11/2004 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN58176213 |
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Study type:
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Interventional |
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Study design:
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Randomised double-blind, placebo controlled, parallel group trial (Treatment)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Saskia A
van Goor |
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Address:
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University Medical Center Groningen
Department of Pathology and Laboratory Medicine
Postblok CMC-V-1 floor
P.O. Box 30001
9700 RB
Groningen
Netherlands |
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Telephone:
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+31 (0)50 3610399 |
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Email:
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s.a.van.goor@lc.umcg.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Apparently healthy pregnant women
2. Para 0 or 1
3. Inclusion should take place prior to the 16th week of pregnancy
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
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Developmental disorder
Mental and Behavioural Disorders
Mixed specific developmental disorders
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Intervention(s)
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Everybody receives a multivitamin supplement (designed for pregnant women). As well as this we compare placebo versus DHA versus DHA/AA.
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Primary Outcome(s)
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Neurological development of the baby (Neurological Optimality Score and General Movements)
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Secondary Outcome(s)
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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)
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Source(s) of Monetary Support
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Not provided at time of registration
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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