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Completed

NCT Number: NCT02626299

Assessment of DHA On Reducing Early Preterm Birth

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Kansas Medical Center, Kansas City, Kansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Docosahexaenoic acid - 800mg/day

Drug

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 names: DHA

Docosahexaenoic acid - 200mg/day

Drug

The control group will receive 1-capsule containing 200 mg DHA/d.

Other names: DHA

Placebo

Other

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.

Primary outcomes

  1. Occurrence of Early Preterm Birth (<34 weeks gestation)

    Time frame: Baseline to 34 Weeks

    Bayesian posterior mean and 95% credible interval of pregnancies which result in an early preterm birth (birth before 34 weeks of pregnancy) by DHA dose

  2. Occurrence of Early Preterm Birth (<34 weeks gestation)

    Time frame: Baseline to 34 weeks

    Bayesian posterior mean and 95% credible interval of pregnancies which result in an early preterm birth (birth before 34 weeks of pregnancy) by DHA dose and DHA status at enrollment (low/high) (modified statistical analysis plan while study was underway)

  3. Maternal and infant adverse and serious adverse events

    Time frame: Enrollment to 30 days past last birth

    Bayesian posterior mean and 95% credible interval by dose

Secondary outcomes

  1. Very low birth weight

    Time frame: At birth

    Bayesian posterior mean and 95% credible interval <1500 grams by dose

  2. Low birth weight

    Time frame: birth

    Bayesian posterior mean and 95% credible interval <2500 grams by dose

  3. Maternal and infant DHA status

    Time frame: birth

    Bayesian posterior mean and 95% credible interval red blood cell phospholipid DHA (weight percent of total fatty acids) at enrollment and birth by dose

  4. Gestational age

    Time frame: birth

    Bayesian posterior mean and 95% credible interval weeks gestation at birth by dose

  5. Birth weight

    Time frame: birth

    Bayesian posterior mean and 95% credible interval in grams by dose

  6. Length and head circumference

    Time frame: birth

    Bayesian posterior mean and 95% credible interval in centimeters by dose

  7. Preterm birth (<37 weeks)

    Time frame: birth

    Bayesian posterior mean and 95% credible interval in weeks by dose

  8. Preterm birth (<37 weeks)

    Time frame: birth

    Number of pregnancies ending in preterm birth by dose

  9. Pre-eclampsia

    Time frame: 12-20 weeks gestation through birth at an average of 40 weeks

    Bayesian posterior mean and 95% credible interval

  10. Pre-eclampsia

    Time frame: 12-20 weeks gestation through birth at an average of 40 weeks

    Number of patients with pre-eclampsia by dose

  11. Gestational diabetes

    Time frame: 12-20 weeks gestation through birth at an average of 40 weeks

    Bayesian posterior mean and 95% credible interval by dose

  12. Gestational diabetes

    Time frame: 12-20 weeks gestation through birth at an average of 40 weeks

    Number of patients with gestational diabetes by dose

  13. Cesarean section

    Time frame: birth

    Bayesian posterior mean and 95% credible interval by dose

  14. Cesarean section

    Time frame: birth

    Number of patients with c-section by dose

  15. Spontaneous labor

    Time frame: birth

    Bayesian posterior mean and 95% credible interval by dose

  16. Spontaneous labor

    Time frame: birth

    Number of patients with spontaneous labor by dose

  17. Admissiion of neonate to a neonatal intensive care unit

    Time frame: birth

    Bayesian posterior mean and 95% credible interval by dose

  18. Admissiion of neonate to a neonatal intensive care unit

    Time frame: birth

    Number of neonates admited to a neonatal intensive care unit by dose

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Nationwide Children's Hospital
  • Ohio State University
  • University of Cincinnati

Registry information

Official study title

Assessment of DHA On Reducing Early Preterm Birth (ADORE Trial)

Acronym: ADORE

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 10, 2015
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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