Bed SoresNCT07813975
Evaluating the Impact of Vitamin D Supplementation on Healing Bed Sores in ICU.
A study testing Enteral Vit-D 3 (cholecalciferol) in people with Bed Sores, run by Maha Salah at 1 site in Egypt.
Trial summary
To study the value of vitamin D supplementation on healing bed sores in ICU patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bed Sores
- What is being tested?
- Enteral Vit-D 3 (cholecalciferol)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Sep 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo
Maha Salah Dr., lecturer, +201007269331, mahata5deer@gmail.com
About this study
To study the value of vitamin D supplementation on healing bed sores in ICU patients.
Read the detailed description
Vitamin D deficiency is a prevalent and clinically significant factor associated with adverse outcomes in critically ill patients, including increased mortality, prolonged hospital stays, and delayed wound healing, particularly pressure ulcers. Given the established link between low vitamin D levels (25-hydroxyvitamin D [25(OH)D] < 20 ng/mL) and these complications, this study aims to investigate the impact of a high-dose vitamin D3 supplementation regimen (250,000 IU over five days) on facilitating Bed Sores healing in ICU patients. By elevating 25(OH)D concentrations to a therapeutic range (>30 ng/mL), we hypothesize that this intervention will contribute to enhanced patient outcomes.
- Conditions
- Bed Sores
- Being tested
- Enteral Vit-D 3 (cholecalciferol)
- Keywords
- bed sores, vitamin D, ICU, NPUAP
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Enteral Vit-D 3 (cholecalciferol) |
| Group B (Control Group) | No intervention | No exogenous Vitamin D will be taken. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The mean change in plasma 25(OH)D concentration from baseline (Day 0, before administration of the study intervention) to Day 7. The change is calculated as:
Change = 25(OH)D concentration at Day 7 - 25(OH)D concentration at baseline
The outcome is generally reported in ng/mL (or nmol/L). A positive change indicates an increase in vitamin D concentration, while a negative change indicates a decrease.
Measured: Baseline (Day 0) to Day 7 - approximately 7 days after initiation/administration of the study intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start6 Sep 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bed SoresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maha Salah
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Sponsor-investigator, Maha Salah, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813975
- Sponsor's protocol ID
- FMASU MS 434/2025
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Vitamin D Supplementation on Healing Bed Sores in ICU.
- ClinicalTrials.gov ID
- NCT07813975
- Acronym / sponsor ID
- FMASU MS 434/2025
- Conditions
- Bed Sores
- Keywords
- bed sores, vitamin D, ICU, NPUAP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Maha SalahUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 6 Sep 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the value of vitamin D supplementation on healing bed sores in ICU patients.
Detailed description
Vitamin D deficiency is a prevalent and clinically significant factor associated with adverse outcomes in critically ill patients, including increased mortality, prolonged hospital stays, and delayed wound healing, particularly pressure ulcers. Given the established link between low vitamin D levels (25-hydroxyvitamin D [25(OH)D] < 20 ng/mL) and these complications, this study aims to investigate the impact of a high-dose vitamin D3 supplementation regimen (250,000 IU over five days) on facilitating Bed Sores healing in ICU patients. By elevating 25(OH)D concentrations to a therapeutic range (>30 ng/mL), we hypothesize that this intervention will contribute to enhanced patient outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Intervention group) | Active comparator | Drug: Enteral Vit-D 3 (cholecalciferol)* 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). |
| Group B (Control Group) | No intervention | –No exogenous Vitamin D will be taken. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteral Vit-D 3 (cholecalciferol)50000 I.U. of vitamin d3 dissolved in 45 mL of milk daily for 5 consecutive days (total dose of 250,000 I.U.) | Drug | Group A (Intervention group) |
Primary outcome
Change in Pressure Ulcer Healing From Baseline to Day 7, Assessed Using the Pressure Ulcer Scale for Healing (PUSH) Tool
Time frame: Baseline (Day 0) to Day 7 after initiation of the study intervention.
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.
1 secondary outcome
Mean Change in Plasma 25-Hydroxyvitamin D [25(OH)D] Concentration From Baseline to Day 7
Time frame: Baseline (Day 0) to Day 7 - approximately 7 days after initiation/administration of the study intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral Vit-D 3 (cholecalciferol) in people with Bed Sores, run by Maha Salah at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maha Salah Dr., lecturer (+201007269331, mahata5deer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pressure Ulcer Healing From Baseline to Day 7, Assessed Using the Pressure Ulcer Scale for Healing (PUSH) Tool (time frame: Baseline (Day 0) to Day 7 after initiation of the study intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.