Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/05/2014
Date assigned
20/08/2014
Last edited
01/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 don’t 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

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/09/2014

Overall trial end date

28/02/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy women with singleton pregnancy

Participant type

Patient

Age group

Adult

Gender

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

Sudan

Trial 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
United Kingdom
-
d.palmer-brown@londonmet.ac.uk

Sponsor type

University/education

Website

http://www.londonmet.ac.uk

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

01/04/2016: Ethics approval information added.