Plain English Summary
Background and study aims
It is vital that pregnant women eat a healthy diet that contains essential nutrients such as folic acid and calcium. It is widely acknowledged that another nutrient, DHA omega 3 (docosahexaenoic acid) is also very important; it is needed for the normal development of the babies brain, eyes and nervous system. Babies in the womb are not really able to produce DHA and therefore must get it from their mother though the placenta. DHA is also considered to have health benefits for the mother. Alpha-linolenic acid (ALA) omega -3 can be converted into DHA. The body cannot make ALA so this has to be eaten as part of a healthy diet. ALA can be found is small amounts in most vegetable oils and in greater amounts in flaxseed, soybeans, walnuts and olive oil. DHA is found in significant amounts in sea food. However, many people do not eat enough DHA and/or ALA rich foods, and that includes those from richer countries. It has been recommended that pregnant women and nursing mothers eat 300 mg/d and at least 200mg/d of DHA every day, but these are only estimates. In an earlier study, we compared the amount of DHA in British pregnant women and their newborn babies (neonates) with those from Sudan. It was found that the level of DHA in Sudanese mothers and their newborn babies were considerably lower than for those from Britain (50% lower in the blood plasma and 85% lower in breast milk). Here, we want to know whether giving the Sudanese mothers 200 or even 300 mg/d DHA supplements would increase DHA levels in the blood plasma and breast milk to match the levels found in British women who dont take the supplement. The aims of the study are: to find out the amount of DHA supplement needed to increase the levels in Sudanese expectant and nursing mothers to those commonly observed in British women; find out whether DHA supplementation before birth is enough to raise the amount of DHA in breast milk to that found in women who receive the supplementation before and after birth; find out how DHA supplementation can affect growth on the unborn baby, the likelihood of premature birth, the weight of the baby at birth and also the size of its head and length.
Who can participate?
Healthy pregnant women expecting one child.
What does the study involve?
Participants are randomly allocated into one of three groups. Those in group 1 are asked to take 575 mg omega 3 FA (contains 322.5 mg DHA & 47.2 mg EPA). Those in group B take 1,725 mg omega 3 FA (contains 967.7 mg DHA & 141.5 mg EPA). Those in group 3 take a placebo (dummy) pill. Blood will be collected at the start of the trial, at time of delivery (from both the mother and cord) and then at 6 weeks after birth. Placenta tissue will be obtained at delivery. Participants will be asked to provide a sample of breast milk 6 weeks after the birth of their baby.
What are the possible benefits and risks of participating?
DHA supplement during pregnancy is known to be beneficial for the eye and brain development of the neonates. There is no risk of participating.
Where is the study run from?
The study has been set up by the Lipidomics and Nutrition Research Centre, Faculty of Life Sciences and Computing, London Metropolitan University (UK) in collaboration with the University of Khartoum Hospital, Khartoum (Sudan).
When is study starting and how long is it expected to run for?
September 2014 to February 2017
Who is funding the study?
Lipidomics and Nutrition Research Centre (UK)
University of Khartoum Hospital (Sudan)
Efamol Limited (UK)
Who is the main contact?
Professor Kebreab Ghebremeskel
k.ghebremeskel@londonmet.ac.uk OR keb@kebgm.demon.co.uk
Study website
Contact information
Type
Scientific
Contact name
Prof Kebreab Ghebremeskel
ORCID ID
Contact details
Lipidomics and Nutrition Research Centre
Faculty of Life Sciences and Computing
London Metropolitan University
166-220 Holloway Road
London
N7 8DB
United Kingdom
-
k.ghebremeskel@londonmet.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
DHA4PREG
Study information
Scientific title
DHA supplementation to improve maternal, foetal and infant outcomes: is the current recommendation appropriate for women with very low intake and status?
Acronym
DHA4PREG
Study hypothesis
1. Supplemented pregnant and lactating Sudanese women and their unsupplemented counterparts have comparable blood and breast milk DHA concentrations
2. Sudanese women who received antenatal supplementation and those supplemented during pregnancy and lactation periods have similar levels of breast milk DHA at postnatal week 6
3. DHA supplementation will not have significant effects on foetal growth, premature delivery, gestation week at delivery and birth anthropometry (birth weight, head circumference and length)
Ethics approval(s)
Research Ethics Committee of the Faculty of Medicine, University of Khartoum, Sudan, 09/09/2014,
ref: FM/DO/EC
Study design
Double-blind placebo-controlled randomised intervention trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pregnancy
Intervention
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)
Intervention type
Supplement
Primary outcome measure
DHA level in maternal and cord blood at delivery
Secondary outcome measures
1. DHA level in breast milk at postnatal week 6
2. Anthropometric measurement of babies at birth and postnatal week 6
Overall study start date
01/09/2014
Overall study end date
28/02/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy women with singleton pregnancy
Participant type(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
180
Participant 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
Recruitment start date
01/09/2014
Recruitment end date
28/02/2017
Locations
Countries of recruitment
England, Sudan, United Kingdom
Study participating centre
London Metropolitan University
London
N7 8DB
United Kingdom
Sponsor information
Organisation
Faculty of Life Sciences and Computing, London Metropolitan University (UK)
Sponsor details
166-220 Holloway Road
London
N7 8DB
England
United Kingdom
-
d.palmer-brown@londonmet.ac.uk
Sponsor type
University/education
Website
ROR
Funders
Funder type
University/education
Funder name
Lipidomics and Nutrition Research Centre, London Metropolitan University, London (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Khartoum Hospital (Sudan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Efamol Limited (UK)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|