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The Effect of Melatonin and Vitamin C on COVID-19

Primary Purpose

Covid19, SARS-CoV Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin C
melatonin
Placebo
Symptom Survey
Sponsored by
Lancaster General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Covid19 focused on measuring vitamin c, melatonin

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lancaster General Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Experimental- Melatonin

Experimental- Vit C

Control

Arm Description

Patients will receive melatonin

Patients will receive vitamin C

Patients will receive placebo

Outcomes

Primary Outcome Measures

Symptom Severity
Symptom severity will be tracked electronically

Secondary Outcome Measures

Symptom progression
Determine symptom course of those with moderate or severe symptoms

Full Information

First Posted
August 26, 2020
Last Updated
August 16, 2022
Sponsor
Lancaster General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04530539
Brief Title
The Effect of Melatonin and Vitamin C on COVID-19
Official Title
The Effect of Melatonin and Vitamin C on COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
August 11, 2022 (Actual)
Study Completion Date
August 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lancaster General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, SARS-CoV Infection
Keywords
vitamin c, melatonin

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental- Melatonin
Arm Type
Experimental
Arm Description
Patients will receive melatonin
Arm Title
Experimental- Vit C
Arm Type
Experimental
Arm Description
Patients will receive vitamin C
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin C
Other Intervention Name(s)
ascorbic acid
Intervention Description
1000mg Vitamin C, at bedtime
Intervention Type
Dietary Supplement
Intervention Name(s)
melatonin
Intervention Description
10mg melatonin, at bedtime
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo at bedtime
Intervention Type
Other
Intervention Name(s)
Symptom Survey
Intervention Description
Daily symptom survey to be completed by patient electronically
Primary Outcome Measure Information:
Title
Symptom Severity
Description
Symptom severity will be tracked electronically
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Symptom progression
Description
Determine symptom course of those with moderate or severe symptoms
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corey Fogleman
Organizational Affiliation
Penn Medicine Lancaster General Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Corey Fogleman, MD
Organizational Affiliation
Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lancaster General Health
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Melatonin and Vitamin C on COVID-19

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