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Melatonin for Glycemic Control in Gestational Diabetes Mellitus

NCT07369284 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-01-27

No results posted yet for this study

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

Conditions

  • Gestational Diabetes

Interventions

DRUG

Melatonin

1. Melatonin tablets will be administered orally 0.5 to 1 hour before sleep and at least 2 hours after the last meal. 2. Participants will take 5 mg melatonin every night during the first week of intervention after randomization, followed by 10 mg melatonin every night from the second week until delivery.

OTHER

Placebo

1. Identical placebo tablets in terms of packaging, appearance, smell and taste will be administered orally 0.5 to 1 hour before sleep and at least 2 hours after the last meal. 2. Participants will take identical placebo tablets after randomization until delivery.

Sponsors & Collaborators

  • West China Second University Hospital

    collaborator OTHER

  • Obstetrics & Gynecology Hospital of Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2027-06-30
Completion
2027-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07369284 on ClinicalTrials.gov