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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
Information provided by (Responsible Party):
Lancaster General Hospital

Tracking Information
First Submitted Date  ICMJE August 26, 2020
First Posted Date  ICMJE August 28, 2020
Last Update Posted Date August 17, 2022
Actual Study Start Date  ICMJE October 5, 2020
Actual Primary Completion Date August 11, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2020)
Symptom Severity [ Time Frame: 14 days ]
Symptom severity will be tracked electronically
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2020)
Symptom progression [ Time Frame: 14 days ]
Determine symptom course of those with moderate or severe symptoms
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE The Effect of Melatonin and Vitamin C on COVID-19
Official Title  ICMJE The Effect of Melatonin and Vitamin C on COVID-19
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Covid19
  • SARS-CoV Infection
Intervention  ICMJE
  • Dietary Supplement: Vitamin C
    1000mg Vitamin C, at bedtime
    Other Name: ascorbic acid
  • Dietary Supplement: melatonin
    10mg melatonin, at bedtime
  • Dietary Supplement: Placebo
    Placebo at bedtime
  • Other: Symptom Survey
    Daily symptom survey to be completed by patient electronically
Study Arms  ICMJE
  • Experimental: Experimental- Melatonin
    Patients will receive melatonin
    • Dietary Supplement: melatonin
    • Other: Symptom Survey
  • Experimental: Experimental- Vit C
    Patients will receive vitamin C
    • Dietary Supplement: Vitamin C
    • Other: Symptom Survey
  • Placebo Comparator: Control
    Patients will receive placebo
    • Dietary Supplement: Placebo
    • Other: Symptom Survey
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2021)
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2020)
Actual Study Completion Date  ICMJE August 11, 2022
Actual Primary Completion Date August 11, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04530539
Other Study ID Numbers  ICMJE 2020-68
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Lancaster General Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Lancaster General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Corey Fogleman Penn Medicine Lancaster General Health
Principal Investigator: Corey Fogleman, MD Physician
PRS Account Lancaster General Hospital
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP