Cardiac Valve Replacement ComplicationPhase 4NCT04085770
Short Term Effect of Vitamin D Supplementation on the Clinical Outcomes in Patients Undergoing Valve Replacement Surgery
A Phase 4 study testing Alfacalcidol 1 MCG Oral Capsule in people with Cardiac Valve Replacement Complication, run by Cairo University at 1 site in Egypt.
Trial summary
This study evaluates the effect of Vitamin D supplementation on ICU and hospital LOS in patients undergoing valve replacement surgery. Half of the patients will receive Alfacalcidol, while the other half-the control group- will be exposed to the same environment without receiving alfacalcidol. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiac Valve Replacement Complication
- What is being tested?
- Alfacalcidol 1 MCG Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2017to 3 Sep 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing mechanical valve replacement surgery
Who cannot join
- combined valvular replacement surgery and Coronary Artery Bypass Graft (CABG) surgery
- valvular replacement redo
- valvular replacement surgery secondary to infective endocarditis
- on dialysis
- ALT levels 2-3 times higher than normal range
- CHD,
Show all 11Show fewer
- impaired gastrointestinal function
- indication for vitamin D supplementation within the prior month
- hypercalcemia defined as total calcium >10.4 mg/dl
- hyperphosphatemia defined as serum phosphate > 4.5 mg/dl
- pregnancy and lactation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
El-Demerdash Cardiac Academy Hospital, Ain Shams University
Cairo, 11562
About this study
This study evaluates the effect of Vitamin D supplementation on ICU and hospital LOS in patients undergoing valve replacement surgery. Half of the patients will receive Alfacalcidol, while the other half-the control group- will be exposed to the same environment without receiving alfacalcidol.
Read the detailed description
Vitamin D insufficiency has been reported in more than 80% of critically ill patients, hospitalized in intensive care unit (ICU), including cardiac surgical patients. Moreover, 25(OH)D levels continue to decrease from baseline throughout the hospital stay and resolves by 6 months. Vitamin D levels < 20 ng/ml is associated with higher mortality, infection rates and prolonged length of ICU saty.
The discovery of vitamin D receptors (VDR) expressed on cardiac muscle and vasculature, released a strong hypothesis suggesting that vitamin D regulates RAAS activity and cardiac remodeling.
The beneficial effects of vitamin D on cardiovascular system, immune function and wound healing could be of particular interest in critical care, and patients undergoing valve replacement surgery will benefit the most.
- Conditions
- Cardiac Valve Replacement Complication
- Being tested
- Alfacalcidol 1 MCG Oral Capsule
- Keywords
- LOS, mediastinitis, secondary myocardial infection
- Medical subject headings
- Mediastinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alfacalcidol 1 MCG Oral CapsuleDrug
Also called Bone care
2 mcg of oral Bone Care© soft gelatin capsules once daily with food starting from the day of admission till the end of hospital stay
| Study group | Role | What they receive |
|---|---|---|
| Alfacalcidol | Experimental | Patients allocated to the alfacalcidol group received 2 mcg of oral Bone Care© soft gelatin capsules once daily with food starting from the day of admission till the end of hospital stay. Receives: Drug: Alfacalcidol 1 MCG Oral Capsule |
| Control | No intervention | Control group were exposed to the same conditions as the treatment group except they were not given one-alfacalcidol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital length of stay
length of hospital stay in days starting from ICU admission to hospital discharge.
Measured: time to hospital discharge, up to 15 days
intensive-care unite length of stay
length of hospital stay in hours starting from ICU admission to ICU discharge.
Measured: time to ICU discharge, up to 7 days
Secondary outcomes (3)
Rate of postoperative complications
compare rate of postoperative infections, decline in LV functions, MI or massive bleeding between the 2 arms
Measured: during hospital stay, up to 15 days
mortality
compare mortality rate between the 2 arms
Measured: during hospital stay, up to 15 days
monitor alfacalcidol safety
the measurement of alfacalcidol blood concentration indirectly through the measurement of serum 25(OH)D and monitoring of its metabolic effect through the measurement of serum total calcium and phosphorous
Measured: during hospital stay, up tp 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start1 Apr 2017
- Primary completion26 Feb 2018
- Study completion3 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Valve Replacement ComplicationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized ,controlled, open-label, parallel clinical trial
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Nael Naguib Wahba, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085770
- Sponsor's protocol ID
- CL(1686)
- Status last verified
- Sep 2019
- First submitted
- 3 Sep 2019
- Last updated
- 11 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naguib SN, Sabry NA, Farid SF, Alansary AM. Short-term Effects of Alfacalcidol on Hospital Length of Stay in Patients Undergoing Valve Replacement Surgery: A Randomized Clinical Trial. Clin Ther. 2021 Jan;43(1):e1-e18. doi: 10.1016/j.clinthera.2020.11.008. Epub 2020 Dec 16.
PubMed 33339609
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Effect of Vitamin D Supplementation on the Clinical Outcomes in Patients Undergoing Valve Replacement Surgery
- ClinicalTrials.gov ID
- NCT04085770
- Acronym / sponsor ID
- CL(1686)
- Conditions
- Cardiac Valve Replacement Complication
- Keywords
- LOS, mediastinitis, secondary myocardial infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 26 Feb 2018 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 11 Sep 2019 (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.
This study evaluates the effect of Vitamin D supplementation on ICU and hospital LOS in patients undergoing valve replacement surgery. Half of the patients will receive Alfacalcidol, while the other half-the control group- will be exposed to the same environment without receiving alfacalcidol.
Detailed description
Vitamin D insufficiency has been reported in more than 80% of critically ill patients, hospitalized in intensive care unit (ICU), including cardiac surgical patients. Moreover, 25(OH)D levels continue to decrease from baseline throughout the hospital stay and resolves by 6 months. Vitamin D levels < 20 ng/ml is associated with higher mortality, infection rates and prolonged length of ICU saty.
The discovery of vitamin D receptors (VDR) expressed on cardiac muscle and vasculature, released a strong hypothesis suggesting that vitamin D regulates RAAS activity and cardiac remodeling.
The beneficial effects of vitamin D on cardiovascular system, immune function and wound healing could be of particular interest in critical care, and patients undergoing valve replacement surgery will benefit the most.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized ,controlled, open-label, parallel clinical trial
| Arm | Type | Receives |
|---|---|---|
| Alfacalcidol | Experimental | Drug: Alfacalcidol 1 MCG Oral CapsulePatients allocated to the alfacalcidol group received 2 mcg of oral Bone Care© soft gelatin capsules once daily with food starting from the day of admission till the end of hospital stay. |
| Control | No intervention | –Control group were exposed to the same conditions as the treatment group except they were not given one-alfacalcidol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing mechanical valve replacement surgery
Key exclusion criteria (11 listed)
- combined valvular replacement surgery and Coronary Artery Bypass Graft (CABG) surgery
- valvular replacement redo
- valvular replacement surgery secondary to infective endocarditis
- on dialysis
- ALT levels 2-3 times higher than normal range
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 |
|---|---|---|
| Alfacalcidol 1 MCG Oral CapsuleAlso: Bone care2 mcg of oral Bone Care© soft gelatin capsules once daily with food starting from the day of admission till the end of hospital stay | Drug | Alfacalcidol |
Primary outcome
hospital length of stay
Time frame: time to hospital discharge, up to 15 days
length of hospital stay in days starting from ICU admission to hospital discharge.
intensive-care unite length of stay
Time frame: time to ICU discharge, up to 7 days
length of hospital stay in hours starting from ICU admission to ICU discharge.
3 secondary outcomes
Rate of postoperative complications
Time frame: during hospital stay, up to 15 days
mortality
Time frame: during hospital stay, up to 15 days
monitor alfacalcidol safety
Time frame: during hospital stay, up tp 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Derived from this study: PubMed 33339609Naguib SN, Sabry NA, Farid SF, Alansary AM. Short-term Effects of Alfacalcidol on Hospital Length of Stay in Patients Undergoing Valve Replacement Surgery: A Randomized Clinical Trial. Clin Ther. 2021 Jan;43(1):e1-e18. doi: 10.1016/j.clinthera.2020.11.008. Epub 2020 Dec 16.
- Individual participant dataSharing planned: No
Related trials for Cardiac Valve Replacement Complication
Active, not recruitingObservational study
Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement
Prosthesis Survival, Prosthesis; Cardiac, Heart, Functional Disturbance as Result
Not yet recruiting
Comparing Suture vs. Combined Closure Strategies for Large Blood Vessel Access in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)
Aortic Valve Stenosis, Postoperative Complications
Not yet recruiting
FROST-STERN Trial: A Trial of Intraoperative Cryoablation for Post Operative Pain Management After Full Sternotomy
Pulmonary Dysfunction, Median Sternotomy Recovery
RecruitingObservational study
Identification of Epigenetic Risk Factors for Ischemic Complication During the TAVR Procedure in the Elderly
Cognitive Decline, Stroke
Recruiting
MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)
Coronary Artery Disease, Aortic Valve Stenosis
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alfacalcidol 1 MCG Oral Capsule in people with Cardiac Valve Replacement Complication, run by Cairo University 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 1 inclusion and 11 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: finished, as of the sponsor's last update on 11 Sep 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospital length of stay (time frame: time to hospital discharge, up to 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04085770, which also lists 1 linked publication.
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 11 Sep 2019.