Omega 3 Supplements During PregnancyNCT03040856
The Effect of Alpha Linolenic Acid (ALA) Supplementation During Pregnancy
A study testing Alpha Linolenic Acid and Omega 3 enriched diet ( DHA+EPA) in people with Omega 3 Supplements During Pregnancy, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Omega 3 Supplements During Pregnancy
- What is being tested?
- Alpha Linolenic Acid and Omega 3 enriched diet ( DHA+EPA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2022to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-42
- Singleton
- Gestational age 12-16 during first visit at the high risk unit
Who cannot join
- Liver Disease
- Dyslipidemia
- Twins
- Warfarin, LMWH, Heparin use ( Due to suspected drug interaction that has been reported however has not been proven yet)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
DHA (Docosahexaenoic Acid ) is a long chain omega-3 fatty acid important for brain and eye development and function throughout life. It also supports heart health. DHA is the most abundant omega-3 in the brain and retina and is naturally found in breast milk. EPA (Eicosapentaenoic Acid ) is a long-chain omega-3 fatty acid important for overall health. However, unlike DHA, the body does not store EPA in significant quantities in the brain or retina (DHA is found in every cell throughout the body, EPA is not). These Omega 3 fatty acids are considered essential due to the inability of the human body to create them and the need to consume them from nutritional source. Food that is considered rich in omega 3 fatty acids are fat fish and green vegetables. 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.
Alpha Linolenic Acid (ALA) is a shorter-chain omega-3 that serves as a source of energy and as a building block for long-chain omega-3 fatty acids (DHA and EPA). This precursor for omega 3 fatty acid is abundant in falx seeds. The mother and the fetus has the metabolic mechanism that enables them to transform ALA into EPA,DHA endogenously.
Women during pregnancy are predisposed to a reduction in unsaturated long chain fatty acid (Polyunsaturated Fatty Acid = PUFA) from the omega 3 group . Lately, a new hypothesis claiming that a reduced level of this essential acids expose the fetus later in his adult life to a spectrum of metabolic and cardiovascular disease. New publication on animal models showed higher rates of obesity, insulin resistance diabetes and cardiovascular damage on mice exposed short chain fatty acids compared to those treated with enriched ALA diet supplementation. Different nutritional and gynecological health organization around the world including the FDA, recommend incorporating omega 3 fatty acids supplementation to daily diet and specifically in pregnant women in order to raise their blood levels for the developing fetus. However, normal fatty acid profile of the omega 3 group in mother and fetus haven't been described yet. Furthermore, the total effect and future benefit to fetus haven't been thoroughly studied and is based mainly on presumptions.
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.
Study methods:
Women 12 weeks of gestation visiting high risk unit and fitting inclusion criteria will be offered to participate in the study. Demographic, medical and obstetrical information will be collected from medical files after giving signed informed consent .
Each participant will be randomly assigned to one of three arms of the study based on the order of being recruited (1- to first group, 2- to second group, 3 - to third group, 4- to first group, etc.). Randomization will be done by the principal investigator that is not one of the high risk unit team, and will be blinded to the participants and the treating doctor.
Group 1: 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).
Group 2: Enriched diet with 2 capsules of DHA+EPA supplementation a day (Each capsule consist of 240 mg DHA and 360 mg EPA) Group 3: Control group - Will receive 2 placebo capsule a day (All products will be supplied by the same company that is approved by the FDA and the Israeli health ministry) Follow up will take place on every visit to the high risk unit that is 3 and 2 weeks apart at the second and third trimester, respectively. On each visit one blood tube that include 5cc of blood will be taken for fatty acid profile analysis and on labor 2 blood tubes will be taken from the mother and from the umbilical cord after separation of the placenta : 1- for fatty acid analysis , 2- for PCR evaluation of mRNAs of genes that were found correlated in animal models to be influenced by maternal diet during pregnancy and are connected to metabolic syndrome pathologies in adulthood ( including - FASn, Elov6, PPAR (α, β/δ, γ), SCD1, Fads2, SREBP-1 Ppargc1alpha, Lpin1, Plin5 , MAPK/PGC-1α. (
- Conditions
- Omega 3 Supplements During Pregnancy
- Being tested
- Alpha Linolenic Acid, Omega 3 enriched diet ( DHA+EPA), Placebo
- Keywords
- Omega 3, Supplements, Alpha Linolenic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha Linolenic AcidDietary supplement
Alpha Linolenic Acid enriched diet
Omega 3 enriched diet ( DHA+EPA)Dietary supplement
Omega 3 (DHA+EPA) supplementation enriched diet
PlaceboOther
Placebo capsules containing olive oil
| Study group | Role | What they receive |
|---|---|---|
| Alpha Linolenic Acid enriched diet | Experimental | 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). Receives: Dietary Supplement: Alpha Linolenic Acid |
| Omega 3 enriched diet ( DHA+EPA) | Experimental | Enriched diet with 2 capsules of DHA+EPA supplementation a day (Each capsule consist of 240 mg DHA and 360 mg EPA). Receives: Dietary Supplement: Omega 3 enriched diet ( DHA+EPA) |
| Placebo | Placebo comparator | Control group - Will receive 2 placebo capsule a day - containing olive oil Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Omega 3 fatty acids ( DHA, EPA, ALA)
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).
Measured: Change in maternal levels of Omega 3 fatty acids ( DHA, EPA, ALA) from recruitment (12 week of gestation ) until delivery .
Secondary outcomes (1)
Expression of messenger RNAs ( mRNAs) between the study groups
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)
Measured: At delivery - Immediately after separation of the placenta ( Blood sample from the mother and from the umbilical cord)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start1 Feb 2022 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Why it stopped: Problems executing the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Omega 3 Supplements During PregnancyStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Aya Mohr-Sasson, Sheba Medical Center
- Investigators
- Israel Hendler, M.D, Study director, Department of Obstetrics and Gynecology ,Sheba Medical Center, Ramat Gan, IsraelAlicia Leikin-Frenkel, M.D, Ph.d, Study director, Bert Strassburger Lipid Center, Sheba Medical Center, Ramat Gan, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040856
- Sponsor's protocol ID
- 3503-16-SMC
- Status last verified
- Apr 2022
- First submitted
- 1 Feb 2017
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu JC, Raine A, Ang RP, Fung DS. An analysis of blinding success in a randomised controlled trial of fish oil omega-3 fatty acids. Ann Acad Med Singap. 2015 Mar;44(3):85-91.
PubMed 25882235Grey A, Bolland M. Clinical trial evidence and use of fish oil supplements. JAMA Intern Med. 2014 Mar;174(3):460-2. doi: 10.1001/jamainternmed.2013.12765. No abstract available.
PubMed 24352849Tsyb AF, Parshkov EM, Sokolov VA. [Major trends of research at the Research Institute of Medical Radiology of the USSR Academy of Medical Sciences under the 12th 5-Year Plan]. Med Radiol (Mosk). 1987 Sep;32(9):6-10. No abstract available. Russian.
PubMed 3657456Hure A, Young A, Smith R, Collins C. Diet and pregnancy status in Australian women. Public Health Nutr. 2009 Jun;12(6):853-61. doi: 10.1017/S1368980008003212. Epub 2008 Jul 23.
PubMed 18647425Diet, nutrition and the prevention of chronic diseases. World Health Organ Tech Rep Ser. 2003;916:i-viii, 1-149, backcover.
PubMed 12768890Kris-Etherton PM, Innis S, Ammerican Dietetic Assocition, Dietitians of Canada. Position of the American Dietetic Association and Dietitians of Canada: dietary fatty acids. J Am Diet Assoc. 2007 Sep;107(9):1599-611.
PubMed 17936958Harris WS, Mozaffarian D, Lefevre M, Toner CD, Colombo J, Cunnane SC, Holden JM, Klurfeld DM, Morris MC, Whelan J. Towards establishing dietary reference intakes for eicosapentaenoic and docosahexaenoic acids. J Nutr. 2009 Apr;139(4):804S-19S. doi: 10.3945/jn.108.101329. Epub 2009 Feb 25.
PubMed 19244379Innis SM. Essential fatty acid transfer and fetal development. Placenta. 2005 Apr;26 Suppl A:S70-5. doi: 10.1016/j.placenta.2005.01.005.
PubMed 15837071Weaver KL, Ivester P, Seeds M, Case LD, Arm JP, Chilton FH. Effect of dietary fatty acids on inflammatory gene expression in healthy humans. J Biol Chem. 2009 Jun 5;284(23):15400-7. doi: 10.1074/jbc.M109.004861. Epub 2009 Apr 9.
PubMed 19359242Casanova MA, Medeiros F, Trindade M, Cohen C, Oigman W, Neves MF. Omega-3 fatty acids supplementation improves endothelial function and arterial stiffness in hypertensive patients with hypertriglyceridemia and high cardiovascular risk. J Am Soc Hypertens. 2017 Jan;11(1):10-19. doi: 10.1016/j.jash.2016.10.004. Epub 2016 Oct 26.
PubMed 27876342Shomonov-Wagner L, Raz A, Leikin-Frenkel A. Alpha linolenic acid in maternal diet halts the lipid disarray due to saturated fatty acids in the liver of mice offspring at weaning. Lipids Health Dis. 2015 Feb 26;14:14. doi: 10.1186/s12944-015-0012-7.
PubMed 25889505Hollander KS, Tempel Brami C, Konikoff FM, Fainaru M, Leikin-Frenkel A. Dietary enrichment with alpha-linolenic acid during pregnancy attenuates insulin resistance in adult offspring in mice. Arch Physiol Biochem. 2014 Jul;120(3):99-111. doi: 10.3109/13813455.2014.940352. Epub 2014 Jul 17.
PubMed 25030769Leikin-Frenkel AI. Is there A Role for Alpha-Linolenic Acid in the Fetal Programming of Health? J Clin Med. 2016 Mar 23;5(4):40. doi: 10.3390/jcm5040040.
PubMed 27023621Leikin-Frenkel A, Shomonov-Wagner L, Juknat A, Pasmanik-Chor M. Maternal Diet Enriched with alpha-Linolenic or Saturated Fatty Acids Differentially Regulates Gene Expression in the Liver of Mouse Offspring. J Nutrigenet Nutrigenomics. 2015;8(4-6):185-94. doi: 10.1159/000442945. Epub 2016 Jan 21.
PubMed 26788914Leikin-Frenkel A, Goldiner I, Leikin-Gobbi D, Rosenberg R, Bonen H, Litvak A, Bernheim J, Konikoff FM, Gilat T. Treatment of preestablished diet-induced fatty liver by oral fatty acid-bile acid conjugates in rodents. Eur J Gastroenterol Hepatol. 2008 Dec;20(12):1205-13. doi: 10.1097/MEG.0b013e3282fc9743.
PubMed 18989145
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03040856
- Acronym / sponsor ID
- 3503-16-SMC
- Conditions
- Omega 3 Supplements During Pregnancy
- Keywords
- Omega 3, Supplements, Alpha Linolenic Acid
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Problems executing the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
DHA (Docosahexaenoic Acid ) is a long chain omega-3 fatty acid important for brain and eye development and function throughout life. It also supports heart health. DHA is the most abundant omega-3 in the brain and retina and is naturally found in breast milk. EPA (Eicosapentaenoic Acid ) is a long-chain omega-3 fatty acid important for overall health. However, unlike DHA, the body does not store EPA in significant quantities in the brain or retina (DHA is found in every cell throughout the body, EPA is not). These Omega 3 fatty acids are considered essential due to the inability of the human body to create them and the need to consume them from nutritional source. Food that is considered rich in omega 3 fatty acids are fat fish and green vegetables. 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.
Alpha Linolenic Acid (ALA) is a shorter-chain omega-3 that serves as a source of energy and as a building block for long-chain omega-3 fatty acids (DHA and EPA). This precursor for omega 3 fatty acid is abundant in falx seeds. The mother and the fetus has the metabolic mechanism that enables them to transform ALA into EPA,DHA endogenously.
Women during pregnancy are predisposed to a reduction in unsaturated long chain fatty acid (Polyunsaturated Fatty Acid = PUFA) from the omega 3 group . Lately, a new hypothesis claiming that a reduced level of this essential acids expose the fetus later in his adult life to a spectrum of metabolic and cardiovascular disease. New publication on animal models showed higher rates of obesity, insulin resistance diabetes and cardiovascular damage on mice exposed short chain fatty acids compared to those treated with enriched ALA diet supplementation. Different nutritional and gynecological health organization around the world including the FDA, recommend incorporating omega 3 fatty acids supplementation to daily diet and specifically in pregnant women in order to raise their blood levels for the developing fetus. However, normal fatty acid profile of the omega 3 group in mother and fetus haven't been described yet. Furthermore, the total effect and future benefit to fetus haven't been thoroughly studied and is based mainly on presumptions.
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.
Study methods:
Women 12 weeks of gestation visiting high risk unit and fitting inclusion criteria will be offered to participate in the study. Demographic, medical and obstetrical information will be collected from medical files after giving signed informed consent .
Each participant will be randomly assigned to one of three arms of the study based on the order of being recruited (1- to first group, 2- to second group, 3 - to third group, 4- to first group, etc.). Randomization will be done by the principal investigator that is not one of the high risk unit team, and will be blinded to the participants and the treating doctor.
Group 1: 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).
Group 2: Enriched diet with 2 capsules of DHA+EPA supplementation a day (Each capsule consist of 240 mg DHA and 360 mg EPA) Group 3: Control group - Will receive 2 placebo capsule a day (All products will be supplied by the same company that is approved by the FDA and the Israeli health ministry) Follow up will take place on every visit to the high risk unit that is 3 and 2 weeks apart at the second and third trimester, respectively. On each visit one blood tube that include 5cc of blood will be taken for fatty acid profile analysis and on labor 2 blood tubes will be taken from the mother and from the umbilical cord after separation of the placenta : 1- for fatty acid analysis , 2- for PCR evaluation of mRNAs of genes that were found correlated in animal models to be influenced by maternal diet during pregnancy and are connected to metabolic syndrome pathologies in adulthood ( including - FASn, Elov6, PPAR (α, β/δ, γ), SCD1, Fads2, SREBP-1 Ppargc1alpha, Lpin1, Plin5 , MAPK/PGC-1α. (
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alpha Linolenic Acid enriched diet | Experimental | Dietary Supplement: Alpha Linolenic AcidEnriched 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). |
| Omega 3 enriched diet ( DHA+EPA) | Experimental | Dietary Supplement: 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). |
| Placebo | Placebo comparator | Other: PlaceboControl group - Will receive 2 placebo capsule a day - containing olive oil |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-42
- Singleton
- Gestational age 12-16 during first visit at the high risk unit
Key exclusion criteria (4 listed)
- Liver Disease
- Dyslipidemia
- Twins
- Warfarin, LMWH, Heparin use ( Due to suspected drug interaction that has been reported however has not been proven yet)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha Linolenic AcidAlpha Linolenic Acid enriched diet | Dietary supplement | Alpha Linolenic Acid enriched diet |
| Omega 3 enriched diet ( DHA+EPA)Omega 3 (DHA+EPA) supplementation enriched diet | Dietary supplement | Omega 3 enriched diet ( DHA+EPA) |
| PlaceboPlacebo capsules containing olive oil | Other | Placebo |
Primary outcome
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).
1 secondary outcome
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Results publication: PubMed 25882235Liu JC, Raine A, Ang RP, Fung DS. An analysis of blinding success in a randomised controlled trial of fish oil omega-3 fatty acids. Ann Acad Med Singap. 2015 Mar;44(3):85-91.
- Results publication: PubMed 24352849Grey A, Bolland M. Clinical trial evidence and use of fish oil supplements. JAMA Intern Med. 2014 Mar;174(3):460-2. doi: 10.1001/jamainternmed.2013.12765. No abstract available.
- Results publication: PubMed 3657456Tsyb AF, Parshkov EM, Sokolov VA. [Major trends of research at the Research Institute of Medical Radiology of the USSR Academy of Medical Sciences under the 12th 5-Year Plan]. Med Radiol (Mosk). 1987 Sep;32(9):6-10. No abstract available. Russian.
- Results publication: PubMed 18647425Hure A, Young A, Smith R, Collins C. Diet and pregnancy status in Australian women. Public Health Nutr. 2009 Jun;12(6):853-61. doi: 10.1017/S1368980008003212. Epub 2008 Jul 23.
- Results publication: PubMed 12768890Diet, nutrition and the prevention of chronic diseases. World Health Organ Tech Rep Ser. 2003;916:i-viii, 1-149, backcover.
- Results publication: PubMed 17936958Kris-Etherton PM, Innis S, Ammerican Dietetic Assocition, Dietitians of Canada. Position of the American Dietetic Association and Dietitians of Canada: dietary fatty acids. J Am Diet Assoc. 2007 Sep;107(9):1599-611.
- Results publication: PubMed 19244379Harris WS, Mozaffarian D, Lefevre M, Toner CD, Colombo J, Cunnane SC, Holden JM, Klurfeld DM, Morris MC, Whelan J. Towards establishing dietary reference intakes for eicosapentaenoic and docosahexaenoic acids. J Nutr. 2009 Apr;139(4):804S-19S. doi: 10.3945/jn.108.101329. Epub 2009 Feb 25.
- Results publication: PubMed 15837071Innis SM. Essential fatty acid transfer and fetal development. Placenta. 2005 Apr;26 Suppl A:S70-5. doi: 10.1016/j.placenta.2005.01.005.
- Results publication: PubMed 19359242Weaver KL, Ivester P, Seeds M, Case LD, Arm JP, Chilton FH. Effect of dietary fatty acids on inflammatory gene expression in healthy humans. J Biol Chem. 2009 Jun 5;284(23):15400-7. doi: 10.1074/jbc.M109.004861. Epub 2009 Apr 9.
- Results publication: PubMed 27876342Casanova MA, Medeiros F, Trindade M, Cohen C, Oigman W, Neves MF. Omega-3 fatty acids supplementation improves endothelial function and arterial stiffness in hypertensive patients with hypertriglyceridemia and high cardiovascular risk. J Am Soc Hypertens. 2017 Jan;11(1):10-19. doi: 10.1016/j.jash.2016.10.004. Epub 2016 Oct 26.
- Results publication: PubMed 25889505Shomonov-Wagner L, Raz A, Leikin-Frenkel A. Alpha linolenic acid in maternal diet halts the lipid disarray due to saturated fatty acids in the liver of mice offspring at weaning. Lipids Health Dis. 2015 Feb 26;14:14. doi: 10.1186/s12944-015-0012-7.
- Results publication: PubMed 25030769Hollander KS, Tempel Brami C, Konikoff FM, Fainaru M, Leikin-Frenkel A. Dietary enrichment with alpha-linolenic acid during pregnancy attenuates insulin resistance in adult offspring in mice. Arch Physiol Biochem. 2014 Jul;120(3):99-111. doi: 10.3109/13813455.2014.940352. Epub 2014 Jul 17.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Israel Hendler, M.D study director
Department of Obstetrics and Gynecology ,Sheba Medical Center, Ramat Gan, Israel
Alicia Leikin-Frenkel, M.D, Ph.d study director
Bert Strassburger Lipid Center, Sheba Medical Center, Ramat Gan, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha Linolenic Acid and Omega 3 enriched diet ( DHA+EPA) in people with Omega 3 Supplements During Pregnancy, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03040856, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.