Recruiting

Fiber Supplementation

Sponsor:

Eastern Virginia Medical School

Code:

NCT06867861

Conditions

Gestational Diabetes Mellitus (GDM)

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Fiber

Study Details

Brief summary:

The hypotheses to be tested are 1) Fiber supplementation will decrease the need for medication in patients with gestational diabetes, and 2) Fiber supplementation will decrease adverse maternal and neonatal outcomes in these patients. In this study, the investigators will conduct a randomized controlled trial to limit bias in evaluating these hypotheses.

Conditions

Gestational Diabetes Mellitus (GDM)

Study ID

NCT06867861

Start date

Feb 24, 2025

Status verified date

Mar, 2025

Completion date

Aug 26, 2026

Anticipated

Primary completion date

Feb 24, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Singleton gestation
  • Known or new diagnosis of gestational diabetes without reason for medication
  • Age >=18 to <=50

Exclusion Criteria:

  • - Non-English as primary language.
  • Known or suspected fetal anomaly or aneuploidy.
  • Known lower bowel disorder
  • Known phenylketonuria
  • Prisoners.
  • Management of diabetes outside of Eastern Virginia Medical School Maternal Fetal Medicine.

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Fiber

Participants will psyllium fiber supplement capsules, 2g soluble fiber per capsule. They will be instructed to take 4 capsules twice daily for a total of 16g supplemental soluble fiber per day. This will be continued throughout pregnancy.

no intervention: No Fiber

Participants will receive no fiber supplementation capsules.

Interventions

Fiber

Psyllium fiber supplement capsules, 2g soluble fiber per capsule. They will be instructed to take 4 capsules twice daily for a total of 16g supplemental soluble fiber per day. This will be continued throughout pregnancy.

Primary outcome measure

  • Number of Participants with Need for GDM Medication [ Time Frame: From date of randomization until the date of first documented progression (assessed up to 7 months) ]

Central Contacts and Locations

Locations

Macon & Joan Brock Virginia Health Sciences at ODU

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Morgan Scaglione, MD

757-446-7900scaglima@odu.edu

Kristin Ayers, MPH

757-446-7900ayerskl@odu.edu

Principal Investigator:

Jerri Waller, MD

More Information

Sponsor

Eastern Virginia Medical School

Last update posted

Mar 10, 2025

Last verified

Mar, 2025

Keywords

  • Gestational Diabetes Mellitus
  • Fiber
  • GDM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eastern Virginia Medical School on 2025-03-10.