RecruitingNot ApplicableNCT06867861

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

Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes: A Randomized Controlled Trial


Sponsor

Eastern Virginia Medical School

Enrollment

110 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria3

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

Exclusion Criteria6

  • \- 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.

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Interventions

DIETARY_SUPPLEMENTFiber

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.


Locations(1)

Macon & Joan Brock Virginia Health Sciences at ODU

Norfolk, Virginia, United States

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NCT06867861


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