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| Name | Class |
|---|---|
| University of Cincinnati | OTHER |
| Ohio State University | OTHER |
| Nationwide Children's Hospital | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200 mg/day DHA | Placebo Comparator | 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. |
|
| 1000 mg/day DHA | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Early Preterm Birth (<34 weeks gestation) | 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 | Baseline to 34 Weeks |
| Occurrence of Early Preterm Birth (<34 weeks gestation) | 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) | Baseline to 34 weeks |
| Maternal and infant adverse and serious adverse events | Bayesian posterior mean and 95% credible interval by dose | Enrollment to 30 days past last birth |
| Measure | Description | Time Frame |
|---|---|---|
| Very low birth weight | Bayesian posterior mean and 95% credible interval <1500 grams by dose | At birth |
| Low birth weight | Bayesian posterior mean and 95% credible interval <2500 grams by dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan E. Carlson, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States | ||
| University of Cincinnati |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37806075 | Derived | Wang Y, Gajewski BJ, Valentine CJ, Crawford SA, Brown AR, Mudaranthakam DP, Camargo JT, Carlson SE. DHA, nutrient intake, and maternal characteristics as predictors of pregnancy outcomes in a randomised clinical trial of DHA supplementation. Clin Nutr. 2023 Nov;42(11):2229-2240. doi: 10.1016/j.clnu.2023.09.005. Epub 2023 Sep 20. | |
| 36680919 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 13, 2022 | |
| Reset | Jul 7, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 13, 2022 | Jul 7, 2022 |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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|
| Docosahexaenoic acid - 200mg/day | Drug | The control group will receive 1-capsule containing 200 mg DHA/d. |
|
|
| 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. |
|
| birth |
| Maternal and infant DHA status | Bayesian posterior mean and 95% credible interval red blood cell phospholipid DHA (weight percent of total fatty acids) at enrollment and birth by dose | birth |
| Gestational age | Bayesian posterior mean and 95% credible interval weeks gestation at birth by dose | birth |
| Birth weight | Bayesian posterior mean and 95% credible interval in grams by dose | birth |
| Length and head circumference | Bayesian posterior mean and 95% credible interval in centimeters by dose | birth |
| Preterm birth (<37 weeks) | Bayesian posterior mean and 95% credible interval in weeks by dose | birth |
| Preterm birth (<37 weeks) | Number of pregnancies ending in preterm birth by dose | birth |
| Pre-eclampsia | Bayesian posterior mean and 95% credible interval | 12-20 weeks gestation through birth at an average of 40 weeks |
| Pre-eclampsia | Number of patients with pre-eclampsia by dose | 12-20 weeks gestation through birth at an average of 40 weeks |
| Gestational diabetes | Bayesian posterior mean and 95% credible interval by dose | 12-20 weeks gestation through birth at an average of 40 weeks |
| Gestational diabetes | Number of patients with gestational diabetes by dose | 12-20 weeks gestation through birth at an average of 40 weeks |
| Cesarean section | Bayesian posterior mean and 95% credible interval by dose | birth |
| Cesarean section | Number of patients with c-section by dose | birth |
| Spontaneous labor | Bayesian posterior mean and 95% credible interval by dose | birth |
| Spontaneous labor | Number of patients with spontaneous labor by dose | birth |
| Admissiion of neonate to a neonatal intensive care unit | Bayesian posterior mean and 95% credible interval by dose | birth |
| Admissiion of neonate to a neonatal intensive care unit | Number of neonates admited to a neonatal intensive care unit by dose | birth |
| Cincinnati |
| Ohio |
| 45220 |
| United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Carlson SE, Gajewski BJ, Valentine CJ, Sands SA, Brown AR, Kerling EH, Crawford SA, Buhimschi CS, Weiner CP, Cackovic M, DeFranco EA, Mudaranthakam DP, Rogers LK. Early and late preterm birth rates in participants adherent to randomly assigned high dose docosahexaenoic acid (DHA) supplementation in pregnancy. Clin Nutr. 2023 Feb;42(2):235-243. doi: 10.1016/j.clnu.2023.01.009. Epub 2023 Jan 11. |
| 34941552 | Derived | Mudaranthakam DP, Brown A, Kerling E, Carlson SE, Valentine CJ, Gajewski B. The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study. JMIR Form Res. 2021 Dec 22;5(12):e30368. doi: 10.2196/30368. |
| 34308309 | Derived | Carlson SE, Gajewski BJ, Valentine CJ, Kerling EH, Weiner CP, Cackovic M, Buhimschi CS, Rogers LK, Sands SA, Brown AR, Mudaranthakam DP, Crawford SA, DeFranco EA. Higher dose docosahexaenoic acid supplementation during pregnancy and early preterm birth: A randomised, double-blind, adaptive-design superiority trial. EClinicalMedicine. 2021 May 17;36:100905. doi: 10.1016/j.eclinm.2021.100905. eCollection 2021 Jun. |
| 28193189 | Derived | Carlson SE, Gajewski BJ, Valentine CJ, Rogers LK, Weiner CP, DeFranco EA, Buhimschi CS. Assessment of DHA on reducing early preterm birth: the ADORE randomized controlled trial protocol. BMC Pregnancy Childbirth. 2017 Feb 13;17(1):62. doi: 10.1186/s12884-017-1244-5. |
| D000091642 | Urogenital Diseases |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |