Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes
NCT06867861 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2025-03-10
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)
Interventions
- DIETARY_SUPPLEMENT
-
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.
Sponsors & Collaborators
-
Eastern Virginia Medical School
lead OTHER
Principal Investigators
-
Jerri Waller, MD · Macon & Joan Brock Virginia Health Sciences at Old Dominion University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-24
- Primary Completion
- 2026-02-24
- Completion
- 2026-08-26
Countries
- United States
Study Locations
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