Assessment of DHA On Reducing Early Preterm Birth
Status: | Recruiting |
---|---|
Conditions: | Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/7/2019 |
Start Date: | June 8, 2016 |
End Date: | February 2021 |
Contact: | Beth Kerling, MS, RD |
Email: | ekerling@kumc.edu |
Phone: | (913) 588-5743 |
Assessment of DHA On Reducing Early Preterm Birth (ADORE Trial)
The purpose of this study is to determine if giving a larger amount of DHA than currently
included in some prenatal supplements can reduce early preterm birth (birth before 34 weeks
of pregnancy).
included in some prenatal supplements can reduce early preterm birth (birth before 34 weeks
of pregnancy).
Docosahexaenoic acid (DHA) is a nutrient found in some fish and eggs and its intake in US
diets is typically low. Because DHA is important for early brain development, it has recently
been added to many prenatal supplements. The usual amount is around 200 mg/day. Participants
in this study are guaranteed to receive at least 200 mg/day of DHA.
Almost 5 in 100 births in the US occur before 34 weeks of pregnancy. There is no way to
predict which births will occur before 34 weeks. In an earlier study conducted at the
University of Kansas Medical Center, women who received 600 mg DHA/day compared to no DHA had
fewer births before 34 weeks of pregnancy with fewer complications of preterm birth.
This study is designed to compare standard care (200 mg/day of DHA) to a higher amount of DHA
(1000 mg/day) to determine if the higher amount will reduce early preterm birth (birth before
34 weeks of pregnancy). Individual participation in this study is expected last about 5
months.
diets is typically low. Because DHA is important for early brain development, it has recently
been added to many prenatal supplements. The usual amount is around 200 mg/day. Participants
in this study are guaranteed to receive at least 200 mg/day of DHA.
Almost 5 in 100 births in the US occur before 34 weeks of pregnancy. There is no way to
predict which births will occur before 34 weeks. In an earlier study conducted at the
University of Kansas Medical Center, women who received 600 mg DHA/day compared to no DHA had
fewer births before 34 weeks of pregnancy with fewer complications of preterm birth.
This study is designed to compare standard care (200 mg/day of DHA) to a higher amount of DHA
(1000 mg/day) to determine if the higher amount will reduce early preterm birth (birth before
34 weeks of pregnancy). Individual participation in this study is expected last about 5
months.
Inclusion Criteria:
- Pregnant females 18 years and older 12 to 20 weeks gestation at study entry
- Agree to consume study capsules and a typical prenatal supplement of 200 mg DHA
- Available by telephone
- Able to speak and read in either English or Spanish language
Exclusion Criteria:
- Expecting multiple infants
- Gestational age at baseline <12 weeks or >20 weeks
- Unable or unwilling to agree to consume capsules until delivery
- Unwilling to discontinue use of another prenatal supplement that contains greater than
or equal to 200 mg DHA per day
- Women with allergy to any component of DHA product (including algae), soybean oil or
corn oil
We found this trial at
3
sites
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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2600 Clifton Ave
Cincinnati, Ohio 45267
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Emily DeFranco, DO
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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281 W. Lane Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Catalin Buhimschi, MD
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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