None listed
Conditions
Brief summary
This research project, called the OPAL-3 Study will help us determine the best dose of omega-3 supplements to give pregnant women, who have a moderate level of omega-3. Omega-3 fatty acids (DHA and EPA) are found in fish and fish oils and thought to have several health benefits including maintaining a pregnancy to full term (>37 weeks). Previous studies have shown that women who are low in omega-3 fatty acids are at increased risk of having a premature baby. This risk can be reduced by taking an omega-3 supplement containing DHA and EPA. Studies have also shown that women who have sufficient levels of omega-3 fatty acids have a lower risk of giving birth to a premature baby and do not need to take supplements. What is not clear from the research is the best advice to provide women with moderate omega-3 levels. The aim of this study is to work out the dose of omega-3 fatty acids (DHA and EPA) needed to best match the fatty acid levels of women who are sufficient in omega-3 fatty acids. This study will compare women who have moderate levels of omega-3 and taking different doses of study supplements to women who have sufficient levels of omega-3. We will also compare with women who have low levels of omega-3 and are taking the recommended dose to correct their low levels. This will be done by looking at the omega-3 levels in blood spot samples throughout pregnancy.
Interventions
Pregnant women with moderate omega-3 levels will be randomly assigned (like tossing a coin) to receive one of four doses of omega-3 supplements. Women allocated to each group will be asked to take 4 capsules per day.
The active capsules contain 200mg of DHA and 25 mg of EPA
The placebo or control capsules contain vegetable oil with no DHA and EPA.
Each treatment allocation will contain a different balance of active and control capsules.
Arm 1 - 4 control capsules per day - total of no DHA or
Pregnant women with moderate omega-3 levels will be randomly assigned (like tossing a coin) to receive one of four doses of omega-3 supplements. Women allocated to each group will be asked to take 4 capsules per day. The active capsules contain 200mg of DHA and 25 mg of EPA The placebo or control capsules contain vegetable oil with no DHA and EPA. Each treatment allocation will contain a different balance of active and control capsules. Arm 1 - 4 control capsules per day - total of no DHA or EPA per day Arm 2 - 1 active and 3 control capsules per day - total of 200 mg DHA, 25 mg EPA per day Arm 3 - 2 active and 2 control capsules per day - total of 400 mg DHA, 50 mg EPA per day Arm 4 - 4 active capsules per day - total of 800 mg DHA, 100 mg EPA per day The supplementation period will be from study entry (estimated to be around 21 weeks of gestation) until 37 weeks of gestation or the birth of the baby, whichever comes first.
Sponsors
South Australian Health and Medical Research Institute
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Singleton pregnancy < 21 weeks gestation • Able to give informed consent Randomised Controlled Trial (RCT) Groups only: • Identified as having an omega-3 fatty acid status in the lower end of the moderate range (defined as 3.7% to 4.0%% total fatty acids in serum) Reference groups only: Women with low omega-3 status (serum omega-3 <3.7% total fatty acids and supplemented with 800mg DHA + 100mg EPA per day) OR Women with sufficient or replete status (serum omega-3 >4.3% total fatty acids) and taking no more than 250 mg per day of omega-3 from supplements.
Exclusion criteria
• Allergy to fish • Enrolled in another fatty acid intervention trial throughout pregnancy. • Currently taking heparin (Clexane)
Outcome results
None listed