CClinicalTrials.gg
CompletedNCT04530539Updated Aug 17, 2022

The Effect of Melatonin and Vitamin C on COVID-19

An interventional study of Vitamin C and melatonin in Covid19 and SARS-CoV Infection, sponsored by Lancaster General Hospital. Completed at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-17.

Sponsored by Lancaster General Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Covid19
  • SARS-CoV Infection

Keywords

  • vitamin c
  • melatonin
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 122 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Lancaster General Hospital is the lead sponsor of 19 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
122 participants (actual)

Study arms

  • 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

Interventions

  • Dietary supplementVitamin C

    1000mg Vitamin C, at bedtime

    Also known as: ascorbic acid

  • Dietary supplementmelatonin

    10mg melatonin, at bedtime

  • Dietary supplementPlacebo

    Placebo at bedtime

  • OtherSymptom Survey

    Daily symptom survey to be completed by patient electronically

06

What researchers measure

Primary outcomes

  1. Symptom Severity

    Symptom severity will be tracked electronically

    Time frame: 14 days

Secondary outcomes

  1. Symptom progression

    Determine symptom course of those with moderate or severe symptoms

    Time frame: 14 days

07

Study locations

1 site
  • Lancaster General Health
    Lancaster, Pennsylvania 17602, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04530539
Lead sponsor
Lancaster General Hospital
Responsible party
Sponsor
First posted
Aug 28, 2020
Start date
Oct 5, 2020
Primary completion
Aug 11, 2022
Completion
Aug 11, 2022
Last update
Aug 17, 2022

Study contacts

Corey Fogleman
principal investigator · Penn Medicine Lancaster General Health
Corey Fogleman, MD
principal investigator · Physician

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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