Vitamin D Testing and Treatment for COVID 19

NCT04407286 | Completed Phase 1

• 1 other identifier: STUDY00011960
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This study will measure vitamin D levels in adults with COVID 19. Participants with low levels of vitamin D will be entered into an open label trial of supplementation with vitamin D.

Conditions

Covid 19; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (2)

• Vitamin D levels

  change in level of Vitamin D, 25-Hydroxy between the two time points

  baseline and after two weeks of vitamin D supplementation

• severity of COVID 19 symptoms

  We will calculate the change in severity of COVID 19 symptoms from baseline to 2 weeks after vitamin D supplementation

  baseline and at 2 weeks after vitamin D supplementation

Study Arms (1)

Treatment Group

EXPERIMENTAL

This group will receive vitamin D. The dosage for the first two weeks will be 10,000 IU/day b.i.d. (age 18-69 years) or 15,000 IU/day t.i.d. (age 70+) After two weeks of taking vitamin D, if vitamin D levels are still below 30 ng/ml, continue the dosage for 3 more weeks. If vitamin D levels are 30-49 ng/ml, continue at a dosage of 5000 IU/day. If vitamin D levels are 50+ ng/ml, stop supplementation.

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Oral vitamin D3 capsules

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult age 18 or older
• Previous positive test result for COVID 19

You may not qualify if:

• Participation in Part 1
• Vitamin D level below 30 ng/ml
• No abnormalities on the comprehensive metabolic panel that are clinically significant to increasing the risk of an adverse reaction to vitamin D supplementation
• Liver impairment
• Clinical opinion of study physician that vitamin D supplementation could be harmful to the participant.
• Pregnancy
• No symptoms for 2 weeks after positive COVID 19 test
• Recovered from symptoms

Sponsors & Collaborators

• Arizona State University: lead
• Southwest College of Naturopathic Medicine: collaborator

Study Sites (1)

Arizona State University

Tempe, Arizona, 85287, United States

Location

MeSH Terms

Conditions

COVID-19; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• James B Adams, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

• Sarah Trahan, NMD

  Southwest College of Naturopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open label treatment study for people with COVID 19 and low levels of vitamin D

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 29, 2020
• Study Start: May 19, 2020
• Primary Completion: August 30, 2020
• Study Completion: November 30, 2020
• Last Updated: December 30, 2021

Record last verified: 2021-12

Locations

US (1)