drugset / Trial / NCT07369284
Melatonin for Glycemic Control in Gestational Diabetes Mellitus
Phase 2
Not yet recruiting
150 enrolled
Obstetrics & Gynecology Hospital of Fudan University
West China Second University Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate whether melatonin supplementation improves glycemic control in pregnant women diagnosed with gestational diabetes mellitus (GDM). The main question it aims to answer is: Does melatonin supplementation help with glycemic control, especially in lowering fasting plasma glucose level? Researchers will compare melatonin to a placebo (a look-alike substance that contains no melatonin) to see if melatonin works to improve glycemic control. Participants will: 1. Take melatonin or a placebo every day after randomization until delivery 2. Visit the antenatal clinic once every 1 to 2 weeks for follow-ups
Timeline
- Start
- 2026-02
- Primary completion
- 2027-06
- Completion
- 2027-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melatonin | Small molecule | 10 mg | Oral |