The Effect of Melatonin and Vitamin C on COVID-19

August 16, 2022 updated by: Lancaster General Hospital
This is a double-blind placebo controlled trial that seeks to evaluate the impact of melatonin and vitamin C on symptoms and outcomes of patients with COVID-19.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17602
        • Lancaster General Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • COVID-19 positive test (outpatient testing),
  • Age >50 (chosen based greater risk for older patients to be vitamin deficient, age >65 not used so as not to be too restrictive in the inclusion criteria)
  • Experiencing symptoms for <5 days prior to enrollment
  • Able to read and write in English or Spanish
  • Able to access REDCap daily
  • Valid email address
  • Current has a Lancaster General Health primary care physician

Exclusion Criteria

  • COVID-19 test ordered pre-procedure for asymptomatic screening
  • Currently taking vitamin C supplements
  • Currently taking melatonin supplements
  • Currently hospitalized
  • Deceased
  • Currently pregnant
  • Currently incarcerated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental- Melatonin
Patients will receive melatonin
Dietary supplement: melatonin
10mg melatonin, at bedtime
Other: Symptom Survey
Daily symptom survey to be completed by patient electronically
Experimental: Experimental- Vit C
Patients will receive vitamin C
Other: Symptom Survey
Daily symptom survey to be completed by patient electronically
Dietary supplement: Vitamin C
1000mg Vitamin C, at bedtime
Other Names:
  • ascorbic acid
Placebo Comparator: Control
Patients will receive placebo
Other: Symptom Survey
Daily symptom survey to be completed by patient electronically
Dietary supplement: Placebo
Placebo at bedtime

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom Severity
Time Frame: 14 days
Symptom severity will be tracked electronically
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom progression
Time Frame: 14 days
Determine symptom course of those with moderate or severe symptoms
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lancaster General Hospital

Investigators

  • Principal Investigator: Corey Fogleman, Penn Medicine Lancaster General Health
  • Principal Investigator: Corey Fogleman, MD, Physician

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2020

Primary Completion (Actual)

August 11, 2022

Study Completion (Actual)

August 11, 2022

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 28, 2020

Study Record Updates

Last Update Posted (Actual)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-68

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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