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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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17 October 2016 |
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Main ID: |
ISRCTN03848493 |
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Date of registration:
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20/08/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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DHA for PREGnant women: is the current recommendation appropriate for women with very low intake and status?
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Scientific title:
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DHA supplementation to improve maternal, foetal and infant outcomes: is the current recommendation appropriate for women with very low intake and status? |
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Date of first enrolment:
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01/09/2014 |
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Target sample size:
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180 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN03848493 |
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Study type:
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Interventional |
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Study design:
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Double-blind placebo-controlled randomised intervention trial (Quality of life)
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Phase:
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Countries of recruitment
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Sudan
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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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Kebreab
Ghebremeskel |
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Address:
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Lipidomics and Nutrition Research Centre
Faculty of Life Sciences and Computing, London Metropolitan University
166-220 Holloway Road
N7 8DB
London
United Kingdom |
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Telephone:
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- |
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Email:
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k.ghebremeskel@londonmet.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Healthy women with singleton pregnancy
Exclusion criteria: 1. Pre-existing chronic medical conditions such as diabetes, high blood pressure, congenital heart disease, kidney disease, very preterm delivery
2. Sickle cell disease or hemoglobinopathies
3. History of pre-eclampsia, stillbirth or foetal death, major foetal anomaly
4. Smoking or other illegal-substance abuse
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pregnancy
Nutritional, Metabolic, Endocrine
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Intervention(s)
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Participants will be asked to take one of three supplements:
1. 575 mg omega 3 FA (contains 322.5 mg DHA & 47.2 mg EPA)
2. 1,725 mg omega 3 FA (contains 967.7 mg DHA & 141.5 mg EPA)
3. Placebo (contains no omega-3 fatty acids)
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Primary Outcome(s)
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DHA level in maternal and cord blood at delivery
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Secondary Outcome(s)
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1. DHA level in breast milk at postnatal week 6
2. Anthropometric measurement of babies at birth and postnatal week 6
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Source(s) of Monetary Support
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Lipidomics and Nutrition Research Centre, London Metropolitan University, London (UK), University of Khartoum Hospital (Sudan), Efamol Limited (UK)
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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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