Evaluating the Impact of Vitamin D Supplementation on Healing Bed Sores in ICU.

NCT07813975 | Recruiting DMC

• 1 other identifier: FMASU MS 434/2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To study the value of vitamin D supplementation on healing bed sores in ICU patients.

Conditions

Bed Sores

Keywords

bed sores; vitamin D; ICU; NPUAP

Outcome Measures

Primary Outcomes (1)

• Change in Pressure Ulcer Healing From Baseline to Day 7, Assessed Using the Pressure Ulcer Scale for Healing (PUSH) Tool

  Pressure ulcer healing will be assessed using the Pressure Ulcer Scale for Healing (PUSH). The PUSH tool evaluates wound healing based on wound length × width (surface area), wound exudate amount, and tissue type. A total PUSH score is calculated, with lower scores indicating better healing. The change in PUSH score from baseline to Day 7 will be used to evaluate improvement in pressure-ulcer healing. Calculation: Change in PUSH score = PUSH score at Day 7 - PUSH score at baseline A negative change indicates improvement/healing, whereas a positive change indicates deterioration.

  Baseline (Day 0) to Day 7 after initiation of the study intervention.

Secondary Outcomes (1)

• Mean Change in Plasma 25-Hydroxyvitamin D [25(OH)D] Concentration From Baseline to Day 7

  Baseline (Day 0) to Day 7 - approximately 7 days after initiation/administration of the study intervention.

Study Arms (2)

Group A (Intervention group)

ACTIVE COMPARATOR

* Patients will receive Enteral Vit-D 3 (cholecalciferol) supplementation. * One tablet of Biodal ® containing 50000 I.U. of vitamin d3 dissolved in 45 mL of milk daily for 5 consecutive days (total dose of 250,000 I.U.). * This group will be monitored during the study for Vitamin D toxicity symptoms \& signs of including: vomiting (treated by giving anti emetic ondansetron IV), constipation (treated by giving lactulose syrup as laxative), irritability, Hypercalcemia and Renal impairment (treated by restricting vitamin D and calcium supplements, and fluid adjustment).

Drug: Enteral Vit-D 3 (cholecalciferol)

Group B (Control Group)

NO INTERVENTION

No exogenous Vitamin D will be taken.

Interventions

Enteral Vit-D 3 (cholecalciferol) DRUG

50000 I.U. of vitamin d3 dissolved in 45 mL of milk daily for 5 consecutive days (total dose of 250,000 I.U.)

Group A (Intervention group)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Maha Salah: lead
• Ain Shams University: collaborator

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Maha Salah Dr., lecturer

CONTACT

+201007269331; mahata5deer@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 10, 2026
• Study Start: September 6, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)