Higher dose docosahexaenoic acid supplementation during pregnancy and early preterm birth: A randomised, double-blind, adaptive-design superiority trial
Eclinical Medicine – Lancet May 17, 2021DOI:https://doi.org/10.1016/j.eclinm.2021.100905
Susan E Carlson. Byron J Gajewski, Christina J Valentine, Elizabeth H Kerling, Carl P Weiner, Michael Cackovic, et al.
Note: The standard recommended dose during pregnancy is 200 milligrams
Items in both categories Pregnancy and Omega-3 are listed here:
- Should Omega-3 be mandatory in Pregnancy (yes) – July 2024
- Vitamin D and Omega-3 benefits to pregnancy and infants
- Omega-3 fatty acid in pregnancy reduces risk of preterm and early preterm birth – Feb 2024
- Omega-3 fatty acid in pregnancy reduces risk of preterm and early preterm birth – Feb 2024
- Stillbirth reduced by Vitamin D, Zinc, Omega-3 - several studies
- Preterm birth decreased by Omega-3, etc. - many studies
- Preterm birth reduction by nutrients - Vitamin D is the best, Omega-3 is next best – May 2022
- Omega-3 improves pregnancies – Meta-analysis May 2022
- Omega-3 supplementation reduced preterm birth rate by 4X – RCT July 2020
- Conception 1.5 X more likely if taking any amount of Omega-3 – Feb 2022
- Pre-term birth rate cut in half with 1000 milligrams of Omega-3 (if initially low) – RCT May 2021
- Omega-3 recommended in Australia during pregnancy - April 2021
- Pregnancy recommendations – huge differences in Vitamin D, Mg, iron, Iodine, DHA, etc – April 2021
- Seafood (Omega-3) during pregnancy increased childhood IQ by 8 points – review Dec 2019
- Pregnant women in Australia to take Omega-3 when told of reduction in preterm births – Dec 2019
- Fat-soluble vitamins critical for conception, pregnancy and breast feeding (pigs) – Sept 2019
- Preterm Births reduced by Omega-3, Zinc, and Vitamin D – Aug 2019
- Depression after childbirth 5 X less likely if good Omega-3 index – April 2019
- Infant Problem-Solving Skills Linked to Mother’s DHA Omega-3 Level During Pregnancy – April 2019
- Omega-3 during pregnancy and breastfeeding is recommended – May 2019
- Preterm Births decreased by Omega-3 (analysis of 184 countries) – April 2019
- Preterm Births - promising preventions – anti-oxidants, Vitamin D, Omega-3, Zinc, etc. – Jan 2019
- Preterm birth might be prevented by Vitamin D, Omega-3, etc. (International survey) – Jan 2019
- Omega-3 index of 5 greatly decreases the risk of an early preterm birth – Dec 2018
- Omega-3 added during pregnancy helps in many ways – Cochrane Review of RCTs Nov 2018
- Omega-3 helps conception as well as pregnancy – many studies
- More pregnancies and fewer abortions when Omega-3 was added (cows in this case) July 2018
- PCOS treated by a combination of Vitamin D and Omega-3 – RCT Oct 2018
- Omega-3 – fewer than 5 percent of adult women get the RDA – April 2018
- Omega-3, Vitamin D, Folic acid etc. during pregnancy and subsequent mental illness of child – March 2018
- Supplementation while pregnant and psychotic – 20 percent Omega-3, 6 percent Vitamin D – June 2016
- Importance of Vitamin D and fish rarely mentioned during midwife-led prenatal booking visits – July 2017
- Preterm birth rate of pregnant smokers cut in half if take Omega-3 – RCT May 2017
- Gestational diabetes treated by Vitamin D plus Omega-3 – RCT Feb 2017
- Asthma reduced 31 percent when Omega-3 taken during pregnancy – RCT Dec 2016
- Preterm births strongly related to Vitamin D, Vitamin D Receptor, Iodine, Omega-3, etc
- Typical pregnancy is now 39 weeks – Omega-3 and Vitamin D might restore it to full 40 weeks
- Omega-3 supplementation during pregnancy reduce early preterm births (save 1500 USD per child) – Aug 2016
- Rancid Omega-3 increased the odds of newborn mortality by 13 times (rats) – July 2016
- Preterm birth extended by 2 weeks with Omega-3 – Meta-analysis Nov 2015
- Stillbirth rate typically 1 in 200, perhaps only 1 in 800 with Omega-3
- Omega-3 helps pregnancy in many ways: preterm 26 percent less likely etc – review July 2012
- Pregnancy and infants healthier with Omega-3 supplementation - many studies
- Vitamin D, DHA, Folic, Iodine benefits during pregnancy – July 2012
Vitamin D titles containing pre-term or pre-mature
Comment by VitaminDWiki
Omega-3 and Vitamin D independantly have been found to reduce pre-term births by about half
Omega-3 and Vitamin D have often been found to be synergistic
Suspect that getting the Omega-3 index > 6 and Vitamin D >40 ng could result in a 4X reduction in preterm births
Ensure a healthy pregnancy and baby - take Vitamin D before conception has the following
Preterm births are VERY costly – Feb 2017 contains this cost-analysis
Assumptions: additional $50,000 per premature birth, $100 for education & supplements per pregnancy
| Net savings per birth After subtract all costs | # needed to eliminate 1 preterm | Cost of educ, supp per pregnancy | Total cost Educ/supp. | Cost of test per pregnancy | Total test costs | Net savings after subtract costs | |
| Vitamin D (5,000 IU avg) | $4,300 | 20 | $100 | $2,000 | $200%%%(2 tests) | $4,000 | $43,000 |
| Omega-3 | $646 | 67 | $100 | $6,700 | $0 | $0 | $43,300 |
| Vitamin C reduces early rupture | $646 | 67 | $100 | $6,700 | $0 | $0 | $43,300 |
| Iodine | $320 | 100 | $100 | $10,000 | $80 | $8,000 | $32,000 |
Does not include additional savings to infant beyond the first year
such as reductions in Autism, MS, Respiratory Tract Infection, Asthma, Allergies
Does not include additional savings to mother
such as reduction in preeclampsia, miscarriage, gestational diabetes, depression
nor does it assign any costs for anguish of possible premie death, stillbirth, time off from work, job productivity
FDA now allows claims for both:
Download the PDF from VitaminDWiki
Background
Several meta analyses have concluded n-3 fatty acids, including docosahexaenoic acid (DHA), reduce early preterm birth (EPB, < 34 weeks), however, the amount of DHA required is unclear. We hypothesized that 1000 mg DHA per day would be superior to 200 mg, the amount in most prenatal supplements.
Methods
This randomised, multicentre, double-blind, adaptive-design, superiority trial was conducted in three USA medical centres. Women with singleton pregnancies and 12 to 20 weeks gestation were eligible. randomization was generated in SAS® by site in blocks of 4. The planned adaptive design periodically generated allocation ratios favoring the better performing dose. Managing study personnel were blind to treatment until 30 days after the last birth. The primary outcome was EPB by dose and by enrolment DHA status (low/high). Bayesian posterior probabilities (pp) were determined for planned efficacy and safety outcomes using intention-to-treat. The study is registered with ClinicalTrials.gov (NCT02626299) and closed to enrolment.
Findings
Eleven hundred participants (1000 mg, n = 576; 200 mg, n = 524) were enrolled between June 8, 2016 and March 13, 2020 with the last birth September 5, 2020. 1032 (n = 540 and n = 492) were included in the primary analyses. The higher dose had a lower EPB rate [1.7% (9/540) vs 2.4% (12/492), pp=0.81] especially if participants had low DHA status at enrolment [2.0% (5/249) vs 4.1%, (9/219), pp=0.93]. Participants with high enrolment DHA status did not realize a dose effect [1000 mg: 1.4% (4/289); 200 mg: 1.1% (3/271), pp = 0.57]. The higher dose was associated with fewer serious adverse events (maternal: chorioamnionitis, premature rupture of membranes and pyelonephritis; neonatal: feeding, genitourinary and neurologic problems, all pp>0.90).
Interpretation
Clinicians could consider prescribing 1000 mg DHA daily during pregnancy to reduce EPB in women with low DHA status if they are able to screen for DHA.
Reviewer comment: “The authors noted negative pregnancy outcomes (such as gestational diabetes, preeclampsia, Cesarean delivery, or others), maternal and infant health status (including DHA levels), and serious adverse events post-delivery (such as birth defects, death, or others)”