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Diabetic Retinopathy: Effects of Melatonin Treatment on Visual Functions and Circadian Rhythm

NCT03478306 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-08-02

No results posted yet for this study

Summary

This study evaluates the effect of melatonin 4 mg on circadian rhythm and visual function of patients with diabetes mellitus. Half of the patients will receive melatonin (arm-1) and the other half will receive placebo (arm-2), both groups in 3 weeks. After a week of washout, the patients will cross over to the other treatment arm.

Conditions

  • Diabetic Retinopathy
  • Melatonin
  • Circadian Dysrhythmia
  • Circadian Rhythm Sleep Disorder, Unspecified Type

Interventions

DRUG

Melatonin 4 mg Tablet

Participants are randomized into arm 1 or arm2, recieving melatonin or placebo, respectively, for 21 days, followed by 1 week of washout, and then swichting to the contralateral treatment arm.

Sponsors & Collaborators

  • Steno Diabetes Center Copenhagen

    collaborator OTHER

  • Glostrup University Hospital, Copenhagen

    lead OTHER

Principal Investigators

  • Shakoor Ba-Ali · Department of Ophthalmology, Rigshospitalet-Glostrup

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-27
Primary Completion
2021-06-12
Completion
2021-06-12

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

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 NCT03478306 on ClinicalTrials.gov