Choline Supplementation on Fetal Growth in Gestational Diabetes Mellitus
Public ClinicalTrials.gov record NCT04302168. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Effects of Choline Supplementation on Fetal Growth in Gestational Diabetes Mellitus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04302168
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 46 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2020
- Primary completion
- Aug 29, 2024
- Completion
- Oct 30, 2024
- Last update posted
- Mar 11, 2025
2020 – 2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Maimonides Medical Center | Brooklyn | New York | 11219 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04302168, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 11, 2025 · Synced Sep 12, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04302168 live on ClinicalTrials.gov.