ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Alpha Linolenic Acid (ALA) Supplementation During Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03040856
Recruitment Status : Not yet recruiting
First Posted : February 2, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Aya Mohr-Sasson, Sheba Medical Center

Brief Summary:

Omega-3 fatty acids are "good fats," and are among the most important nutrients lacking in Western diets today. The average person in developing countries consumes less than 100 mg of DHA daily. With increasing awareness of the importance of DHA, many people realize that they need to make a change in their diet by adding DHA-rich foods or supplements.

The aim of this study is to learn the effect of different supplementations from the omega 3 group on the maternal and fetal fatty acid profile during pregnancy and to study their epigenetic influence.


Condition or disease Intervention/treatment Phase
Omega 3 Supplements During Pregnancy Dietary Supplement: Alpha Linolenic Acid Dietary Supplement: Omega 3 enriched diet ( DHA+EPA) Other: Placebo Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Effect of Alpha Linolenic Acid (ALA) Supplementation on Essential Fatty Acids Profile During Pregnancy Compared to Common Supplements and the Epigenetic Effect on the Newborn
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Alpha Linolenic Acid enriched diet
Enriched diet with 2 capsules of ALA supplementation a day - 630 mg in each capsule. Total amount of 1260 mg (Daily recommended dose is 1-2 g).
Dietary Supplement: Alpha Linolenic Acid
Alpha Linolenic Acid enriched diet

Experimental: Omega 3 enriched diet ( DHA+EPA)
Enriched diet with 2 capsules of DHA+EPA supplementation a day (Each capsule consist of 240 mg DHA and 360 mg EPA).
Dietary Supplement: Omega 3 enriched diet ( DHA+EPA)
Omega 3 (DHA+EPA) supplementation enriched diet

Placebo Comparator: Placebo
Control group - Will receive 2 placebo capsule a day - containing olive oil
Other: Placebo
Placebo capsules containing olive oil




Primary Outcome Measures :
  1. Levels of Omega 3 fatty acids ( DHA, EPA, ALA) [ Time Frame: Change in maternal levels of Omega 3 fatty acids ( DHA, EPA, ALA) from recruitment (12 week of gestation ) until delivery . ]
    Change in Omega 3 fatty acids ( DHA, EPA, ALA) blood levels during different gestational weeks of pregnancy until delivery, including umbilical cord blood levels after the separation of the placenta ( third stage of delivery).


Secondary Outcome Measures :
  1. Expression of messenger RNAs ( mRNAs) between the study groups [ Time Frame: At delivery - Immediately after separation of the placenta ( Blood sample from the mother and from the umbilical cord) ]
    Change between study groups in expression of mRNAs in the mother at delivery and in the fetus ( analyzing umbilical cord blood after separation of the placenta) ( including - FASn, Elov6, PPAR (α, β/δ, γ), SCD1, Fads2, SREBP-1 Ppargc1alpha, Lpin1, Plin5 , MAPK/PGC-1α)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-42
  • Singleton
  • Gestational age 12-16 during first visit at the high risk unit

Exclusion Criteria:

  • Liver Disease
  • Dyslipidemia
  • Twins
  • Warfarin, LMWH, Heparin use ( Due to suspected drug interaction that has been reported however has not been proven yet)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040856


Contacts
Contact: Aya Mohr Sasson, M.D +972-3-5302777 mohraya@gmail.com

Sponsors and Collaborators
Sheba Medical Center
Investigators
Study Director: Israel Hendler, M.D Department of Obstetrics and Gynecology ,Sheba Medical Center, Ramat Gan, Israel
Study Director: Alicia Leikin-Frenkel, M.D, Ph.d Bert Strassburger Lipid Center, Sheba Medical Center, Ramat Gan, Israel

Publications of Results:

Responsible Party: Dr. Aya Mohr-Sasson, Principal Investigator, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03040856     History of Changes
Other Study ID Numbers: 3503-16-SMC
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dr. Aya Mohr-Sasson, Sheba Medical Center:
Omega 3
Supplements
Alpha Linolenic Acid