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Assessment of DHA On Reducing Early Preterm Birth (ADORE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by University of Kansas Medical Center
Sponsor:
Collaborators:
University of Cincinnati
Ohio State University
Nationwide Children's Hospital
Information provided by (Responsible Party):
Susan Carlson, PhD, University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT02626299
First received: December 8, 2015
Last updated: September 28, 2016
Last verified: September 2016
  Purpose
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).

Condition Intervention Phase
Preterm Birth
Drug: Docosahexaenoic acid - 800mg/day
Drug: Docosahexaenoic acid - 200mg/day
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Assessment of DHA On Reducing Early Preterm Birth (ADORE Trial)

Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • Occurrence of Early Preterm Birth [ Time Frame: Baseline to 34 Weeks ]
    Count of pregnancies which result in an early preterm birth (birth before 34 weeks of pregnancy).


Secondary Outcome Measures:
  • Change in plasma soluble (s) RAGE concentration (sRAGE) [ Time Frame: Baseline to 34 Weeks ]
    Change in sRAGE will be documented to measure any effect DHA has on it's concentration in the body.

  • Count of Adverse Events [ Time Frame: 34 Weeks ]
    Count of reported adverse events by study participants.


Estimated Enrollment: 1200
Study Start Date: June 2016
Estimated Study Completion Date: February 2021
Estimated Primary Completion Date: February 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 200 mg/day DHA
Participants will receive 2 placebo pills/day that do not contain DHA. Like the experimental group, they will be given a supplement of Docosahexaenoic acid - 200mg/day , a common amount in prenatal vitamins.
Drug: Docosahexaenoic acid - 200mg/day
The control group will receive 1-capsule containing 200 mg DHA/d.
Other Name: DHA
Other: Placebo
Participants will receive 2 capsules (masked) containing half soybean oil and half corn oil equaling 800 mg.The soybean and corn oil combination does not contain DHA.
Experimental: 1000 mg/day DHA
The intervention includes Docosahexaenoic acid - 800mg/day per day provided in two 400 mg capsules. The intervention group as well as the active comparator group will be given 1-200 mg/capsule per day of DHA that is a common amount in prenatal vitamins.
Drug: Docosahexaenoic acid - 800mg/day
All participants will take 1000 mg/DHA per day (1 capsule will be labeled with 200 mg; 2 capsules will be masked with 400 mg each)
Other Name: DHA
Drug: Docosahexaenoic acid - 200mg/day
The control group will receive 1-capsule containing 200 mg DHA/d.
Other Name: DHA

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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 with DHA
  • Women with allergy to any component of DHA product (including algae), soybean oil or corn oil
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02626299

Contacts
Contact: Beth Kerling, MS, RD (913) 588-5743 ekerling@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45220
Principal Investigator: Emily DeFranco, DO         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Catalin Buhimschi, MD         
Sponsors and Collaborators
University of Kansas Medical Center
University of Cincinnati
Ohio State University
Nationwide Children's Hospital
Investigators
Principal Investigator: Susan E. Carlson, PhD University of Kansas Medical Center
  More Information

Responsible Party: Susan Carlson, PhD, Professor, Dietetics and Nutrition, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02626299     History of Changes
Other Study ID Numbers: STUDY00003455 
Study First Received: December 8, 2015
Last Updated: September 28, 2016

Keywords provided by University of Kansas Medical Center:
Preterm birth, very low birth weight

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on February 24, 2017