Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes

Part of paid clinical trials in Norfolk, Virginia.

Sponsor
Eastern Virginia Medical School
Study ID
NCT06867861
Status
Recruiting
Apply to this trial

Conditions

  • Gestational Diabetes Mellitus (GDM)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Fiber — DIETARY_SUPPLEMENT
    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.

Study Details

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.

Key Dates

Start date
Feb 24, 2025
Status verified
Mar 2025
Primary completion
Feb 24, 2026
Completion
Aug 26, 2026

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

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) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Macon & Joan Brock Virginia Health Sciences at ODUNorfolkVirginia23507
Morgan Scaglione, MD
[email protected]
757-446-7900
Kristin Ayers, MPH
[email protected]
757-446-7900
Jerri Waller, MD (PRINCIPAL_INVESTIGATOR)
Morgan Scaglione, MD (SUB_INVESTIGATOR)

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By research site
Macon & Joan Brock Virginia Health Sciences at ODU· Norfolk, VA

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