Replacing Vitamin D in Burn Patients with Deficiency
Vitamin D Deficiency in Adults Following a Major Burn Injury
This study tests if giving burn patients with low Vitamin D either a regular or higher dose can improve their overall health and well-being.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05084248 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Vitamin D supplementation in adults who are deficient following a major burn injury. Participants will be randomly assigned to receive either a standard dose of 400 IU or a higher dose of 4000 IU of Vitamin D daily. The study aims to evaluate the impact of these dosages on various health outcomes, including physical, mental, and social health, using validated measurement tools. The capsules will be identical in appearance to ensure a double-blind design.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have experienced significant burn injuries and have been diagnosed with Vitamin D deficiency.
Not a fit: Patients with severe liver or kidney dysfunction unrelated to their burn injury or those with malignant tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve recovery and overall health outcomes for burn patients suffering from Vitamin D deficiency.
How similar studies have performed: While there is ongoing research into Vitamin D supplementation, this specific approach in burn patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults, 18 years of age or older, who have completed 6 months from time of their burn injury 2. ≥ 10% TBSA, ≥ 65 years of age and Burn Surgery for Wound Closure 3. ≥ 20% TBSA, 18 - 64 of age and Burn Surgery for Wound Closure 4. Electrical high voltage / lightning and Burn Surgery for Wound Closure 5. Hand burn and/or face burn, and/or feet burn and Burn Surgery for Wound Closure 6. May speak English or Spanish 7. Vit. D deficiency Exclusion Criteria: 1. Patients with parathyroid disease, severe liver dysfunction, sever kidney dysfunction, which are not caused by the burn injury 2. Patients with malignant tumors 3. Patients not meeting the inclusion criteria
Where this trial is running
Dallas, Texas
- Parkland Health and Hospital Systems — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Kyra Jeanine Solis, BS
- Email: KyraJeanine.Solis@UTSouthwestern.edu
- Phone: 214-648-3560
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.