Study Stopped
PI has confirmed there are no results because the samples were degraded.
Commerical DHA Supplementation
Serum Docosahexaenoic Acid After Third Trimester Commercially Available Supplementation: a Randomized Clinical Trial
2 other identifiers
interventional
72
1 country
1
Brief Summary
The purpose of this study is to compare blood levels of women who take commericially available, low dose docosahexaenoic acid (DHA) dietary supplements in pregnancy with women who do not take supplements.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 10, 2014
CompletedFirst Posted
Study publicly available on registry
June 13, 2022
CompletedJanuary 11, 2024
January 1, 2024
Same day
June 10, 2014
January 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maternal serum DHA weight % at delivery
Weight proportion of DHA in the total plasma phospholipids after supplementation
5 months
DHA in newborn cord blood after supplementation
Weight proportion of DHA in the total plasma phospholipids of newborn cord blood after maternal supplementation
up to 72 hours
Study Arms (3)
Expecta 200mg DHA supplement
ACTIVE COMPARATORWomen receive one daily softgel 200mg DHA algae-based DHA supplement sold as "Expecta."
Promise 275mg DHA supplement
ACTIVE COMPARATORWomen receive one daily softgel 275mg DHA fish oil-based DHA supplement sold as "Promise."
Control/ no supplement
NO INTERVENTIONWomen received care as usual and did not take any DHA supplement.
Interventions
Eligibility Criteria
You may qualify if:
- Pregnant
- weeks gestational age
You may not qualify if:
- Maternal medical disease
- Gestational diabetes
- Pre-eclampsia
- Fetal anomalies
- Ingestion of DHA or fish oil dietary supplements during the current pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of New Mexico Hospital
Albuquerque, New Mexico, 87131, United States
Related Publications (1)
Wolfe MD, Chuang LT, Rayburn WF, Wen PC, VanderJagt DJ, Glew RH. Low fatty acid concentrations in neonatal cord serum correlate with maternal serum. J Matern Fetal Neonatal Med. 2012 Aug;25(8):1292-6. doi: 10.3109/14767058.2011.631064. Epub 2012 Apr 24.
PMID: 22023348BACKGROUND
Study Officials
- STUDY DIRECTOR
Steffen A Brown, MD
University of New Mexico
- PRINCIPAL INVESTIGATOR
Ellen L Mozurkewich, MD, MS
University of New Mexico
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-investigator
Study Record Dates
First Submitted
June 10, 2014
First Posted
June 13, 2022
Study Start
May 1, 2011
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
January 11, 2024
Record last verified: 2024-01