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RecruitingNCT06867861Updated Mar 10, 2025

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

An interventional study of Fiber in Gestational Diabetes Mellitus (GDM), sponsored by Eastern Virginia Medical School. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-03-10.

Sponsored by Eastern Virginia Medical School · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Feb 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Gestational Diabetes Mellitus (GDM)

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Keywords

  • Gestational Diabetes Mellitus
  • Fiber
  • GDM
03

In context

Diabetes, Gestational

877 studies on the registry are indexed under Diabetes, Gestational; 203 are open to participants now.

This study's planned enrollment of 110 is close to the median of 110 across 564 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Eastern Virginia Medical School is the lead sponsor of 56 studies on the registry; 8 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (estimated)

Study 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.

    Dietary Supplement: Fiber

  • No intervention
    No Fiber

    Participants will receive no fiber supplementation capsules.

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.

06

What researchers measure

Primary outcomes

  1. Number of Participants with Need for GDM Medication

    The primary outcome is the need for medication (either insulin or oral hypoglycemic agents) for management of gestational diabetes (progression from GDMA1 to GDMA2). We chose this primary outcome because the need for medication is associated with the need for significantly more antenatal interventions due to increased adverse pregnancy outcomes.

    Time frame: From date of randomization until the date of first documented progression (assessed up to 7 months)

Secondary outcomes

  1. Hgb A1c at delivery

    Measurement of Hgb A1c

    Time frame: At delivery

  2. Rate of Fetal Demise

    Rate of fetal demise

    Time frame: From date of randomization until the date of documented occurrence (assessed up to 7 months)

  3. Number of Participants Diagnosed with Fetal Growth Restriction

    Number of participants diagnosed with fetal growth restriction

    Time frame: From date of randomization until the date of first documented progression (assessed up to 7 months)

  4. Number of Participants Diagnosed with Preeclampsia

    Number of participants diagnosed with preeclampsia

    Time frame: From date of randomization until the date of first documented progression (assessed up to 7 months)

  5. Number of Participants with Placental Abruption

    Number of participants with placental abruption

    Time frame: From date of randomization until the date of first documented progression (assessed up to 7 months)

  6. Mode of Delivery

    Rates of cesarean and vaginal deliveries

    Time frame: At delivery

  7. Indication for Cesarean Delivery

    Rates of each indication for cesarean delivery

    Time frame: At delivery

  8. Rate of Shoulder Dystocia

    Rate of shoulder dystocia

    Time frame: At delivery

  9. Quantitative Blood Loss

    Blood loss in mL

    Time frame: At delivery

  10. Rate of Postpartum Hemorrhage

    Rates of patients with quantitative blood loss \> 1000mL

    Time frame: At delivery

  11. Rates of Infection

    Rates of infection

    Time frame: Delivery until discharge (assessed up to 5 days)

  12. Birth Weight

    Birth weight

    Time frame: At delivery

  13. Apgar Score

    Apgar scores at delivery on a scale of 0 to 10, with higher scores meaning a better outcome

    Time frame: At delivery

  14. Rates of Neonatal Infections

    Rates of neonatal infections

    Time frame: Delivery until discharge (assessed up to 5 days)

  15. Rate of Respiratory Distress Syndrome

    Rate of respiratory distress syndrome

    Time frame: At delivery

  16. Rate of Necrotizing Enterocolitis

    Rate of necrotizing enterocolitis

    Time frame: Delivery until discharge (assessed up to 5 days)

  17. Rate of NICU Admission

    Rate of admission to NICU

    Time frame: Delivery until discharge (assessed up to 5 days)

  18. Days in NICU

    Days spent in NICU

    Time frame: Delivery until discharge of the neonate (assessed up to 180 days)

07

Study locations

1 of 1 sites recruiting
  • Macon & Joan Brock Virginia Health Sciences at ODU
    Norfolk, Virginia 23507, United States
    Recruiting
    • Morgan Scaglione, MD · Contactscaglima@odu.edu · 757-446-7900
    • Kristin Ayers, MPH · Contactayerskl@odu.edu · 757-446-7900
    • Jerri Waller, MD · Principal investigator
    • Morgan Scaglione, MD · Sub investigator
08

References and documents

Publications

  • ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501. PubMed 29370047 ↗
  • Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, et al. A multicenter, randomized trial of treatment for mild gestational diabetes. Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. N Engl J Med 2009;361:1139-48.
  • Hartling L, Dryden DM, Guthrie A, Muise M, Vandermeer B, Donovan L. Benefits and harms of treating gestational diabetes mellitus: a systematic review and meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research. Ann Intern Med. 2013 Jul 16;159(2):123-9. doi: 10.7326/0003-4819-159-2-201307160-00661. PubMed 23712381 ↗
  • Karter AJ, Subramanian U, Saha C, Crosson JC, Parker MM, Swain BE, Moffet HH, Marrero DG. Barriers to insulin initiation: the translating research into action for diabetes insulin starts project. Diabetes Care. 2010 Apr;33(4):733-5. doi: 10.2337/dc09-1184. Epub 2010 Jan 19. PubMed 20086256 ↗
  • Chandalia M, Garg A, Lutjohann D, von Bergmann K, Grundy SM, Brinkley LJ. Beneficial effects of high dietary fiber intake in patients with type 2 diabetes mellitus. N Engl J Med. 2000 May 11;342(19):1392-8. doi: 10.1056/NEJM200005113421903. PubMed 10805824 ↗
  • Anderson JW, Allgood LD, Turner J, Oeltgen PR, Daggy BP. Effects of psyllium on glucose and serum lipid responses in men with type 2 diabetes and hypercholesterolemia. Am J Clin Nutr. 1999 Oct;70(4):466-73. doi: 10.1093/ajcn/70.4.466. PubMed 10500014 ↗
  • Sun J, Wang J, Ma W, Miao M, Sun G. Effects of Additional Dietary Fiber Supplements on Pregnant Women with Gestational Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Studies. Nutrients. 2022 Nov 2;14(21):4626. doi: 10.3390/nu14214626. PubMed 36364883 ↗
  • Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12. PubMed 15951574 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2025 (actual). Primary completion is estimated for Feb 2026, 12 months after the start.

Of 307 non-industry interventional studies with no phase under Diabetes, Gestational, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 48. This study's planned 12 months is below that.

Counting every sponsor, half of 310 studies reached it within 28 months; a quarter within 13 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2025
First posted
Mar 10, 2025
StartActual
Feb 24, 2025
Primary completionEst.
Feb 24, 2026
CompletionEst.
Aug 26, 2026
Last update
Mar 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06867861
Lead sponsor
Eastern Virginia Medical School
Responsible party
Jerri Waller (Principal Investigator, Eastern Virginia Medical School) — Principal investigator
First posted
Mar 10, 2025
Start date
Feb 24, 2025
Primary completion
Feb 24, 2026 (estimated)
Completion
Aug 26, 2026 (estimated)
Last update
Mar 10, 2025

Study contacts

Jerri Waller, MD
principal investigator · Macon & Joan Brock Virginia Health Sciences at Old Dominion University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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