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Pre-term birth rate cut in half with 1000 milligrams of Omega-3 (if initially low) – RCT May 2021

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.

VitaminDWiki

Note: The standard recommended dose during pregnancy is 200 milligrams

Items in both categories Pregnancy and Omega-3 are listed here:

Vitamin D titles containing pre-term or pre-mature

Items found: 14

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

Start Vitamin D soon if pregnant VDW 9923

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 cost
s
# 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)
$4,30020$100$2,000$200%%%(2 tests)$4,000$43,000
Omega-3 $64667 $100$6,700$0 $0 $43,300
Vitamin C
reduces early rupture
$64667$100$6,700$0$0 $43,300
Iodine $320100$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)”


Created by admin. Last Modification: Saturday June 5, 2021 01:47:30 GMT-0000 by admin. (Version 7)

Attached files

ID Name Comment Uploaded Size Downloads
15710 Omega-3 preterm birth RCT.pdf PDF 2021 admin 04 Jun, 2021 23:02 1.46 Mb 28
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