End Stage Renal DiseaseNCT04967469
Comparison of Serum Calcium Level Between Preoperative Vitamin D and Non-vitamin D Regimen of Total Parathyroidectomy in End-stage Renal Failure Patients in Rajavithi Hospital
A study testing Calcitriol and Alfacalcidol 0.5 MCG Oral Capsule in people with End Stage Renal Disease, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
This Research is compare about IV Calcium between end-stage renal failure patients who take vitamin D and non-vitamin D preoperative parathyroidectomy Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Calcitriol and Alfacalcidol 0.5 MCG Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 1 Sep 2020to 30 Dec 2023
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New End-stage renal failure patients and have iPTH>800 pg/dl at least 6 months
- Patients who no response hyperphosphatemia with high dose vitamin D
Who cannot join
- Allergy vitamin D
- Pregnancy
- Patients who parathyroidectomy have less than 4 gland
Trial locations and contacts
1 site in 1 country.
About this study
This Research is compare about IV Calcium between end-stage renal failure patients who take vitamin D and non-vitamin D preoperative parathyroidectomy
- Conditions
- End Stage Renal Disease
- Being tested
- Calcitriol, Alfacalcidol 0.5 MCG Oral Capsule
- Keywords
- Hypocalcemia, Hyperparathyroidism, End Stage Renal Disease (ESRD), calcitriol
- Medical subject headings
- Kidney Failure, Chronic, Hypocalcemia, Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitriolDrug
end-stage renal failure patients who is hyperparathyroid with ESRD take calcidol preoperative Parathyroidectomy
Alfacalcidol 0.5 MCG Oral CapsuleDrug
end-stage renal failure patients who is hyperparathyroid with ESRD take alfacalcidol preoperative Parathyroidectomy
| Study group | Role | What they receive |
|---|---|---|
| take calcitriol | Experimental | End-stage renal failure patients who is Hyperparathyroid with ESRD take calcitriol Receives: Drug: Calcitriol |
| take alphacalcidol | Experimental | End-stage renal failure patients who is Hyperparathyroid with ESRD take 1-hydroxycholecalciferol (alfacalcidol) Receives: Drug: Alfacalcidol 0.5 MCG Oral Capsule |
| control | No intervention | End-stage renal failure patients who is Hyperparathyroid with ESRD take standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of serum calcium level between patients who take Vitamin D and non-Vitamin D
Comparison of serum calcium level between patients who take Vitamin D and non-Vitamin D
Measured: 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Sep 2020
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967469
- Sponsor's protocol ID
- 63127
- Status last verified
- Aug 2021
- First submitted
- 8 Jul 2021
- Last updated
- 25 Jan 2024
- 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 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Serum Calcium Level Between Preoperative Vitamin D and Non-vitamin D Regimen of Total Parathyroidectomy in End-stage Renal Failure Patients in Rajavithi Hospital
- ClinicalTrials.gov ID
- NCT04967469
- Acronym / sponsor ID
- 63127
- Conditions
- End Stage Renal Disease
- Keywords
- Hypocalcemia, Hyperparathyroidism, End Stage Renal Disease (ESRD), calcitriol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 19 Jul 2021 (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 Research is compare about IV Calcium between end-stage renal failure patients who take vitamin D and non-vitamin D preoperative parathyroidectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| take calcitriol | Experimental | Drug: CalcitriolEnd-stage renal failure patients who is Hyperparathyroid with ESRD take calcitriol |
| take alphacalcidol | Experimental | Drug: Alfacalcidol 0.5 MCG Oral CapsuleEnd-stage renal failure patients who is Hyperparathyroid with ESRD take 1-hydroxycholecalciferol (alfacalcidol) |
| control | No intervention | –End-stage renal failure patients who is Hyperparathyroid with ESRD take standard treatment |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- New End-stage renal failure patients and have iPTH>800 pg/dl at least 6 months
- Patients who no response hyperphosphatemia with high dose vitamin D
Key exclusion criteria (3 listed)
- Allergy vitamin D
- Pregnancy
- Patients who parathyroidectomy have less than 4 gland
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 |
|---|---|---|
| Calcitriolend-stage renal failure patients who is hyperparathyroid with ESRD take calcidol preoperative Parathyroidectomy | Drug | take calcitriol |
| Alfacalcidol 0.5 MCG Oral Capsuleend-stage renal failure patients who is hyperparathyroid with ESRD take alfacalcidol preoperative Parathyroidectomy | Drug | take alphacalcidol |
Primary outcome
Comparison of serum calcium level between patients who take Vitamin D and non-Vitamin D
Time frame: 4 year
Comparison of serum calcium level between patients who take Vitamin D and non-Vitamin D
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 25 Jan 2024.
- 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 study testing Calcitriol and Alfacalcidol 0.5 MCG Oral Capsule in people with End Stage Renal Disease, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 2 inclusion and 3 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 25 Jan 2024. 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 Thailand. 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?
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?
Comparison of serum calcium level between patients who take Vitamin D and non-Vitamin D (time frame: 4 year). 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 25 Jan 2024.