COMPLETED

Vitamin D Deficiency in Adults Following a Major Burn Injury

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a single site double blind randomized controlled trial of replacing Vitamin D for Vitamin D-deficient burn patients at a current recommended dose (400 IU daily) versus a higher dose (4000 IU daily). Capsules will be made in a compounding pharmacy and will look identical. Randomized controlled trial. People who meet the selection criteria will be randomized to either low or high dosage of Vitamin D. Treatment arm is high dose Vitamin D (4000 IU), and control is low dose Vitamin D (400 IU). Main outcome variables include PROMIS-29 measures of physical health, mental health and social health, the Veterans RAND 12 Item Health Survey (VR-12), and the 4-D Itch Scale. Secondary outcome variables include subject demographics, injury demographics and characteristics.

Official Title

Vitamin D Deficiency in Adults Following a Major Burn Injury

Quick Facts

Study Start:2022-09-29
Study Completion:2025-08-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05084248

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adults, 18 years of age or older, who have completed 6 months from time of their burn injury
  2. 2. ≥ 10% TBSA, ≥ 65 years of age and Burn Surgery for Wound Closure
  3. 3. ≥ 20% TBSA, 18 - 64 of age and Burn Surgery for Wound Closure
  4. 4. Electrical high voltage / lightning and Burn Surgery for Wound Closure
  5. 5. Hand burn and/or face burn, and/or feet burn and Burn Surgery for Wound Closure
  6. 6. May speak English or Spanish
  7. 7. Vit. D deficiency
  1. 1. Patients with parathyroid disease, severe liver dysfunction, sever kidney dysfunction, which are not caused by the burn injury
  2. 2. Patients with malignant tumors
  3. 3. Patients not meeting the inclusion criteria

Contacts and Locations

Principal Investigator

Maria Pia Kabamalan
STUDY_CHAIR
UT Southwestern

Study Locations (Sites)

Parkland Health and Hospital Systems
Dallas, Texas, 75235
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Maria Pia Kabamalan, STUDY_CHAIR, UT Southwestern

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-29
Study Completion Date2025-08-18

Study Record Updates

Study Start Date2022-09-29
Study Completion Date2025-08-18

Terms related to this study

Additional Relevant MeSH Terms

  • Vitamin D Deficiency
  • Burns