Hemodialysis ComplicationPhase 2/3NCT03602430
Cholecalciferol on Hemodialysis Patients
A Phase 2/3 study testing Cholecalciferol in people with Hemodialysis Complication and Vitamin D Deficiency, run by Ain Shams University at 1 site in Egypt.
Trial summary
Screening the prevalence of vitamin D deficiency among Egyptian hemodialysis patients on a single center (Ain Shams University hospital). Assessing the effect of the native type of vitamin D (Cholecalciferol) on replenishing its deficiency via extra-renal vitamin D receptors (VDR), among Egyptian hemodialysis… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemodialysis Complication, Vitamin D Deficiency, Vascular Calcification
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 28 Sep 2018
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both sexes aged between 18-75 years
- Patients on HD greater than 3 months at least.
- Stable clinical condition (no hospitalization in the previous 3 months)
- Informed consent in accordance with the Declaration of Helsinki.
- PTH level between 150 - 800 pg/ml.
Who cannot join
- Hypersensitivity to cholecalciferol.
- Participant in an another clinical trial within the past 4 weeks.
- Judged to be unsuitable as a subject by the attending physician.
- Pregnant or breastfeeding female
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cholecalciferol on Hemodialysis Patients
- Screening the prevalence of vitamin D deficiency among Egyptian hemodialysis patients on a single center (Ain Shams University hospital).
- Assessing the effect of the native type of vitamin D (Cholecalciferol) on replenishing its deficiency via extra-renal vitamin D receptors (VDR), among Egyptian hemodialysis patients.
- Assessing the effect of cholecalciferol on vascular calcification among Egyptian hemodialysis patients.
- Assessing the effect of cholecalciferol on Blood pressure, parathyroid hormone.
- Being tested
- Cholecalciferol, Placebo
- Medical subject headings
- Vitamin D Deficiency, Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Native vitamin D
Native vitamin D dose of 200IU to be given once per month to hemodialysis patients
PlaceboDrug
A Placebo ampule will be given to hemodialysis patients once per month with their standard treatment for 3 months period. Same color, odor and size, only without the active constituent.
| Study group | Role | What they receive |
|---|---|---|
| Drug Group | Experimental | twenty-five patients will receive 200.000 IU/month native vitamin D; (Cholecalciferol) orally in addition to their standard treatment for 3 months period Receives: Drug: Cholecalciferol |
| Placebo Group | Placebo comparator | twenty-five patients will receive a placebo ampule with their standard treatment for 3 months period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D level
Target serum Vitamin D level ≥ 30 ng/ml
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jul 2018
- Primary completion15 Sep 2018
- Study completion28 Sep 2018
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 Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona AlShahawey AlSayed Ghazy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602430
- Sponsor's protocol ID
- phCL 36
- Status last verified
- Jan 2019
- First submitted
- 1 Jul 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alshahawey M, El Borolossy R, El Wakeel L, Elsaid T, Sabri NA. The impact of cholecalciferol on markers of vascular calcification in hemodialysis patients: A randomized placebo controlled study. Nutr Metab Cardiovasc Dis. 2021 Feb 8;31(2):626-633. doi: 10.1016/j.numecd.2020.09.014. Epub 2020 Sep 21.
PubMed 33594986
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cholecalciferol on Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03602430
- Acronym / sponsor ID
- phCL 36
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 26 Jul 2018 (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.
- Screening the prevalence of vitamin D deficiency among Egyptian hemodialysis patients on a single center (Ain Shams University hospital).
- Assessing the effect of the native type of vitamin D (Cholecalciferol) on replenishing its deficiency via extra-renal vitamin D receptors (VDR), among Egyptian hemodialysis patients.
- Assessing the effect of cholecalciferol on vascular calcification among Egyptian hemodialysis patients.
- Assessing the effect of cholecalciferol on Blood pressure, parathyroid hormone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Group | Experimental | Drug: Cholecalciferoltwenty-five patients will receive 200.000 IU/month native vitamin D; (Cholecalciferol) orally in addition to their standard treatment for 3 months period |
| Placebo Group | Placebo comparator | Drug: Placebotwenty-five patients will receive a placebo ampule with their standard treatment for 3 months period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Both sexes aged between 18-75 years
- Patients on HD greater than 3 months at least.
- Stable clinical condition (no hospitalization in the previous 3 months)
- Informed consent in accordance with the Declaration of Helsinki.
- PTH level between 150 - 800 pg/ml.
Key exclusion criteria (4 listed)
- Hypersensitivity to cholecalciferol.
- Participant in an another clinical trial within the past 4 weeks.
- Judged to be unsuitable as a subject by the attending physician.
- Pregnant or breastfeeding female
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 |
|---|---|---|
| CholecalciferolAlso: Native vitamin DNative vitamin D dose of 200IU to be given once per month to hemodialysis patients | Drug | Drug Group |
| PlaceboA Placebo ampule will be given to hemodialysis patients once per month with their standard treatment for 3 months period. Same color, odor and size, only without the active constituent. | Drug | Placebo Group |
Primary outcome
Vitamin D level
Time frame: 3 months
Target serum Vitamin D level ≥ 30 ng/ml
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 9 Jan 2019.
- Derived from this study: PubMed 33594986Alshahawey M, El Borolossy R, El Wakeel L, Elsaid T, Sabri NA. The impact of cholecalciferol on markers of vascular calcification in hemodialysis patients: A randomized placebo controlled study. Nutr Metab Cardiovasc Dis. 2021 Feb 8;31(2):626-633. doi: 10.1016/j.numecd.2020.09.014. Epub 2020 Sep 21.
- 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. 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 2/3 study testing Cholecalciferol in people with Hemodialysis Complication and Vitamin D Deficiency, run by Ain Shams 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 5 inclusion and 4 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 9 Jan 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Vitamin D level (time frame: 3 months). 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 NCT03602430, 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 9 Jan 2019.