The Effect of Melatonin and Vitamin C on COVID-19

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ClinicalTrials.gov Identifier: NCT04530539

Recruitment Status : Completed

First Posted : August 28, 2020

Last Update Posted : August 17, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Lancaster General Hospital

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.

Condition or disease	Intervention/treatment	Phase
Covid19 SARS-CoV Infection	Dietary Supplement: Vitamin C Dietary Supplement: melatonin Dietary Supplement: Placebo Other: Symptom Survey	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	122 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Supportive Care
Official Title:	The Effect of Melatonin and Vitamin C on COVID-19
Actual Study Start Date :	October 5, 2020
Actual Primary Completion Date :	August 11, 2022
Actual Study Completion Date :	August 11, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019) Vitamin C

Drug Information available for: Ascorbic acid Melatonin Sodium ascorbate Magnesium ascorbate

Genetic and Rare Diseases Information Center resources: Severe Acute Respiratory Syndrome Acute Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

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	Dietary Supplement: Vitamin C 1000mg Vitamin C, at bedtime Other Name: ascorbic acid Other: Symptom Survey Daily symptom survey to be completed by patient electronically
Placebo Comparator: Control Patients will receive placebo	Dietary Supplement: Placebo Placebo at bedtime Other: Symptom Survey Daily symptom survey to be completed by patient electronically

Outcome Measures

Primary Outcome Measures :

Symptom Severity [ Time Frame: 14 days ]
Symptom severity will be tracked electronically

Secondary Outcome Measures :

Symptom progression [ Time Frame: 14 days ]
Determine symptom course of those with moderate or severe symptoms

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	50 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04530539

Locations

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

Sponsors and Collaborators

Lancaster General Hospital

Investigators

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

More Information

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Responsible Party:	Lancaster General Hospital
ClinicalTrials.gov Identifier:	NCT04530539
Other Study ID Numbers:	2020-68
First Posted:	August 28, 2020 Key Record Dates
Last Update Posted:	August 17, 2022
Last Verified:	August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Lancaster General Hospital:


vitamin c melatonin

Additional relevant MeSH terms:

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COVID-19 Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections	Lung Diseases Respiratory Tract Diseases Ascorbic Acid Melatonin Vitamins Micronutrients Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Central Nervous System Depressants

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