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Effect of Fiber Supplementation on the Need for Medication With Gestational Diabetes: A Randomized Controlled Trial
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.
The study team proposes a randomized controlled trial of women with singleton pregnancies who present with a new diagnosis of diet-controlled gestational diabetes (previously referred to as GDMA1). The participants will be randomized to the intervention group (fiber supplementation) or control group (no fiber supplementation) in 1:1 fashion. The participant will be randomized by a number-generating computer software after recruitment at the new gestational diabetes education class.
Age
18 - 50 years
Sex
FEMALE
Healthy Volunteers
No
Macon & Joan Brock Virginia Health Sciences at ODU
Norfolk, Virginia, United States
Start Date
February 24, 2025
Primary Completion Date
February 24, 2026
Completion Date
August 26, 2026
Last Updated
March 10, 2025
110
ESTIMATED participants
Fiber
DIETARY_SUPPLEMENT
Lead Sponsor
Eastern Virginia Medical School
NCT06896799
NCT06836843
Data Source & Attribution
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