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NCT04302168 · ClinicalTrials.gov registry record · NA
Choline Supplementation on Fetal Growth in Gestational Diabetes Mellitus
A NA study, sponsored by Maimonides Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 46
- Enrollment target
NCT04302168 is a NA study that has completed, run by Maimonides Medical Center. The registered enrollment target is 46 participants.
The verdict
NCT04302168, a NA study, has completed, sponsored by Maimonides Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 46 participants
- Enrollment target
Study Summary
Gestational diabetes mellitus (GDM), characterized by maternal high blood sugar, affects up to 15% of pregnancies worldwide. GDM doubles the risk of fetal growth (i.e. macrosomia, large fetus,) which further predisposes the affected fetus to elevated risks of obesity, diabetes and cardiovascular disease later in life. The placenta mediates macrosomia by increasing fat and glucose transport to the fetus during GDM. Effective methods to normalize placental nutrient transport and prevent macrosomia are lacking. Choline is a semi-essential nutrient found in egg yolks, meat, fish and cruciferous vegetables. The demand for this nutrient increases substantially during pregnancy. Previous research demonstrated that maternal choline supplementation (MCS) normalized placental fat and glucose transport as well as fetal growth and fat mass in GDM mice. In this study, the investigators will recruit pregnant women with GDM and randomized them to receive a choline supplement (470mg/day, a dose with demonstrated safety), or a placebo for 8 weeks, starting after gestational week 28. The investigators will determine the effects of choline on fetal growth as well as the influence of choline on placental transport and epigenetic modifications in growth-related genes in the placenta and umbilical cord. Successful completion of this study will provide valuable insights into the use of choline supplement as a modifier of placental macronutrient homeostasis in GDM to improve fetal growth outcomes.
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Choline supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2020-04-01 |
| Est. Completion | 2024-10-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04302168
The ClinicalTrials.gov registry entry for NCT04302168 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Maimonides Medical Center, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04302168 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04302168 about?
NCT04302168 is a clinical study titled "Choline Supplementation on Fetal Growth in Gestational Diabetes Mellitus". Gestational diabetes mellitus (GDM), characterized by maternal high blood sugar, affects up to 15% of pregnancies worldwide. GDM doubles the risk of fetal growth (i.e. macrosomia, large fetus,) which further predisposes the affected fetus to elevated risks of obesity, diabetes and cardiovascular dis...
What is the current status of trial NCT04302168?
This trial is currently completed. It is a NA study. The enrollment target is 46 participants. The study started on 2020-04-01. Estimated completion is 2024-10-31.
What interventions are being tested in trial NCT04302168?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Choline supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04302168?
This trial is sponsored by Maimonides Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
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