See if high-dose vitamin D helps bed sores heal in ICU patients
Official title: Evaluating the Impact of Vitamin D Supplementation on Healing Bed Sores in ICU.
Run by Ain Shams University · NCT07813975 · Data updated 2026-11-12
This study tests whether giving a high-dose vitamin D supplement helps bed sores heal faster in critically ill ICU patients who are deficient in vitamin D.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | September 6, 2026 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | September 24, 2026 |
| Trial ID | NCT07813975 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-60 with grade 1-2 bed sores, vitamin D deficiency (25(OH)D < 20 ng/mL), enteral access, and adequate organ function who are admitted to the ICU.
✕Probably not a fit
Patients without vitamin D deficiency, with advanced pressure ulcers, or with contraindicating medical conditions may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study enrolls ICU patients with early-stage pressure ulcers and vitamin D deficiency to test a high-dose vitamin D3 regimen (250,000 IU over five days). The goal is to raise 25(OH)D levels above 30 ng/mL and observe effects on wound healing and related outcomes. Participants must have enteral access, be hemodynamically stable, and meet organ function criteria. The study excludes those with terminal illness, recent vitamin D supplementation, or conditions associated with abnormal calcium metabolism. The trial is conducted at Ain Shams University with lead sponsor Maha Salah, in collaboration with Ain Shams University.
Why it matters
Potential benefit: If successful, participants may experience improved healing of bed sores and potentially shorter ICU stays.
How similar studies have gone: Evidence from related research suggests vitamin D can influence wound healing in critical illness, but this exact dosing and ICU bed sore context is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
inclusion criteria: * Critically ill patients with bed sores Grade (1-2), (non-light) exudate admitted to ICUs. * Serum vitamin D \<20 ng/mL. * Both genders. * Age: 18-60 years. * enteral access in place to enable delivery of vitamin D3 and are deemed to be able to tolerate enteral drug administration. * GCS \> 9. * Serum Calcium (8-10 mg/dl). * Serum creatinine less than 1.4 mg/dL. exclusion criteria: * Refusal of the legal guardian of the patient to participate in the study. * Current pregnancy or lactating mother. * Patients who are terminally ill and expected to die in less than 72 hours. * Renal dysfunction (GFR \< 30 mL/min) and the onset of dialysis during the study. * Vitamin D supplementation in the last 15 days. * Hypo/hyper-calcemia (adjusted calcium less than 8 mg/dL or above 10). * History of disorders associated with hypercalcemia (history of cancer with history of hypercalcemia within the past 1 year, hyperparathyroidism, sarcoidosis, nephrolithiasis). * History of parathyroid dysfunction. * Ongoing shock, \[defined as unstable blood pressure despite vasopressor support and mean arterial pressure (MAP) \< 60 mm Hg on at least 3 consecutive readings within a 3-hour period prior to study entry\]. * History of malabsorption syndromes; gastrointestinal intolerance (diarrhea, vomiting, or increased nasogastric aspirates). * History of adverse reaction to vitamin D supplementation. * known history of cirrhosis. * Patients taking any medications that have serious drug interactions with vitamin D like statins, orlistat, aluminum hydroxide (interfere with the absorption of vitamin D), digoxin (can enhance the effects of vitamin D on the heart leading to potential toxicity), and certain diuretics (can cause high calcium levels).
Where it's running
-
Ain Shams University
Cairo, Egypt Recruiting
Study contacts
- Study coordinator: Maha Salah Dr., lecturer
- Email: mahata5deer@gmail.com
- Phone: +201007269331
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.