Vitamin D DeficiencyPhase 4NCT03648528
Cholecalciferol Supplementation Effect on Parathyroid Hormone in Hemodialysis Patients
A Phase 4 study testing cholecalciferol in people with Vitamin D Deficiency and Hemodialysis Patient, run by Cooperativa Asistencia Sindicato Médico Uruguay.
Trial summary
Introduction. Vitamin D regulates mineral metabolism. Its deficiency has been associated with diabetes, cancer and increased mortality. 25OH vitamin D (25VD) is stable and suitable for the evaluation of vitamin D sufficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Deficiency, Hemodialysis Patient
- 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
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2015to May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or over
- signed informed consent form
- ESRD with regular dialysis treatment for at least 3 months
- levels of 25VD < 30 ng / ml
- levels of iPTH >300 ng/ml,
- stable doses of calcitrol or paricalcitol over the last 30 days.
Who cannot join
- Congestive heart failure class III or IV
- unstable angina or myocardial infarction or stroke during the previous 3 months
- active malignant neoplasm
- use of any trial medication
- life expectancy lower than 6 months
- corrected calcemia ≥ 10.5 in the 2 months prior to recruitment
- intake of cholecalciferol or ergocalciferol in the 2 months prior to recruitment
- prospective move to another city or transfer to PD in the following 6 months.
About this study
Official title: Randomized Clinical Trial for The Evaluation of The Effects Of Cholecalciferol Supplementation On The Parathyroid Hormone In Hemodialysis Patients
Introduction. Vitamin D regulates mineral metabolism. Its deficiency has been associated with diabetes, cancer and increased mortality. 25OH vitamin D (25VD) is stable and suitable for the evaluation of vitamin D sufficiency.
The aim of the study is to evaluate whether cholecalciferol supplementation for a period of 12 weeks can normalize decreased 25VD levels and reduce increased parathormone (iPTH) in hemodialysis (HD) patients with a vitamin D deficiency. Secondary aims: to evaluate decrease in inflammation, anemia or use of erythropoietin.
Read more
Design. Randomized, double blind clinical trial in two arms of HD patients with 25OH Vitamin D deficiency and secondary hyperparathyroidism, for a period of 12 weeks.
Population. Patients over 18 years of age on HD for more than 3 months and levels of 25VD < 30 ng / ml and iPTH >300 ng/ml , who sign a consent form. Randomization will be achieved by using a table of random numbers at the pharmacy, and neither doctors nor patients will know which group they have been assigned to.
Treatment. Supplementation will consist of one 5000 IU cholecalciferol tablet or placebo during dialysis for a period of 12 weeks.
Monthly monitoring will include: haemoglobin (g/dl), Calcium (mg/dl), Phosphorous (mg/dl), PTH (ng/ml), epo dose (IU/kg/week), epo resistance (IU/kg/week/g Hb).
At the beginning and end of the study the following will be measured: alkaline Phosphatase (IU/ml), PCR (mg/L), 25VD (ng/ml), ferritin (ng/ml) and transferrin saturation, quality of life (SF36).
During the study, doses of calcitrol or paricalcitol will not be modified. The study will be discontinued if calcemia ≥ 10.5 mg/dL is detected on two occasions.
Size of sample is estimated at 120 patients for a PTH decrease of 20% in 35% of patients in group treated (assuming 15% follow-up losses). Analysis will be done for Intention to treat for the primary outcome.
Ethical aspects: Authorization has been obtained from the Ethics Committee of the institution as regards Good Clinical Practices, Helsinki Declaration and national regulations. The trial will be registered at the Ministry of Health.
Read the detailed description
Introduction. Vitamin D regulates mineral metabolism. Its deficiency has been associated with diabetes, cancer and increased mortality. 25OH vitamin D (25VD) is stable and suitable for the evaluation of vitamin D sufficiency.
The aim of the study is to evaluate whether cholecalciferol supplementation for a period of 12 weeks can normalize decreased levels of 25VD and reduce increased parathormone (iPTH) in hemodialysis (HD) patients with a vitamin D deficiency. Secondary aims: to evaluate decrease in inflammation, anemia or use of erythropoietin (epo).
Design. Randomized, double blind clinical trial in two arms of HD patients with 25VD deficiency and secondary hyperparathyroidism, one arm to be treated with cholecalciferol supplementation and the other with a placebo, for a period of 12 weeks.
Population. Patients over 18 years of age on HD for more than 3 months and levels of 25VD < 30 ng / ml and iPTH >300 ng/ml , who sign a consent form. Once their consent has been obtained, iPTH and 25VD levels will be measured. Randomization will be achieved by using a table of random numbers at the pharmacy, and neither doctors nor patients will know which group they have been assigned to.
Treatment. Supplementation will consist of three 5000 IU cholecalciferol tablets or placebo postdialysis per week during dialysis for a period of 12 weeks.
Monthly monitoring will include: haemoglobin (g/dl), Calcium (mg/dl), Phosphorous (mg/dl), iPTH (ng/ml), epo dose (IU/kg/week), epo resistance (IU/kg/week/g Hb).
At the beginning and end of the study the following will be measured: alkaline Phosphatase (IU/ml), C reactive protein (mg/L), 25VD (ng/ml), ferritin (ng/ml) and transferrin saturation, quality of life (SF36).
During the study, doses of calcitrol or paricalcitol will not be modified. The study will be discontinued if calcemia ≥ 10.5 mg/dL is detected on two occasions.
Size of sample is estimated at 120 patients for a iPTH decrease of 20% in 35% of patients in group treated (assuming 15% follow-up losses). Analysis will be done for Intention to treat for the primary outcome.
Ethical aspects: Authorization has been obtained from the Ethics Committee of the institution as regards Good Clinical Practices, Helsinki Declaration and national regulations. The trial was registered at the Ministry of Health.
- Conditions
- Vitamin D Deficiency, Hemodialysis Patient
- Being tested
- cholecalciferol, placebo
- Keywords
- Vitamin D Deficiency, hyperparathyroidism, hemodialysis
- Medical subject headings
- Vitamin D Deficiency, Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferolDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| cholecaciferol | Experimental | one 5000 IU tablet of 25VD taken during dialysis (3 pills per week) for a period of 12 weeks Receives: Drug: cholecalciferol |
| placebo | Placebo comparator | one tablet of placebo taken during dialysis (3 pills per week) for a period of 12 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
20 % Change in iPTH levels
20% change on final iPTH level
Measured: 12 weeks
normalization of 25VD levels
% of patients achieving normal 25VD levels
Measured: 12 weeks
Secondary outcomes (1)
change of 0.5 g/dL on Hb level or 10% change in erythropoietin dose
change of 0.5 g/dL on Hb level or 10% change in erythropoietin dose
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start15 Oct 2015
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double blind clinical trial in two arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooperativa Asistencia Sindicato Médico Uruguay
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Sola, Cooperativa Asistencia Sindicato Médico Uruguay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648528
- Sponsor's protocol ID
- 2014/004
- Status last verified
- Aug 2018
- First submitted
- 10 Aug 2018
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial for The Evaluation of The Effects Of Cholecalciferol Supplementation On The Parathyroid Hormone In Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03648528
- Acronym / sponsor ID
- 2014/004
- Conditions
- Vitamin D Deficiency, Hemodialysis Patient
- Keywords
- Vitamin D Deficiency, hyperparathyroidism, hemodialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cooperativa Asistencia Sindicato Médico UruguayUniversity, hospital or other
- Study start
- 15 Oct 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 27 Aug 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.
Introduction. Vitamin D regulates mineral metabolism. Its deficiency has been associated with diabetes, cancer and increased mortality. 25OH vitamin D (25VD) is stable and suitable for the evaluation of vitamin D sufficiency.
The aim of the study is to evaluate whether cholecalciferol supplementation for a period of 12 weeks can normalize decreased 25VD levels and reduce increased parathormone (iPTH) in hemodialysis (HD) patients with a vitamin D deficiency. Secondary aims: to evaluate decrease in inflammation, anemia or use of erythropoietin.
Design. Randomized, double blind clinical trial in two arms of HD patients with 25OH Vitamin D deficiency and secondary hyperparathyroidism, for a period of 12 weeks.
Population. Patients over 18 years of age on HD for more than 3 months and levels of 25VD < 30 ng / ml and iPTH >300 ng/ml , who sign a consent form. Randomization will be achieved by using a table of random numbers at the pharmacy, and neither doctors nor patients will know which group they have been assigned to.
Treatment. Supplementation will consist of one 5000 IU cholecalciferol tablet or placebo during dialysis for a period of 12 weeks.
Monthly monitoring will include: haemoglobin (g/dl), Calcium (mg/dl), Phosphorous (mg/dl), PTH (ng/ml), epo dose (IU/kg/week), epo resistance (IU/kg/week/g Hb).
At the beginning and end of the study the following will be measured: alkaline Phosphatase (IU/ml), PCR (mg/L), 25VD (ng/ml), ferritin (ng/ml) and transferrin saturation, quality of life (SF36).
During the study, doses of calcitrol or paricalcitol will not be modified. The study will be discontinued if calcemia ≥ 10.5 mg/dL is detected on two occasions.
Size of sample is estimated at 120 patients for a PTH decrease of 20% in 35% of patients in group treated (assuming 15% follow-up losses). Analysis will be done for Intention to treat for the primary outcome.
Ethical aspects: Authorization has been obtained from the Ethics Committee of the institution as regards Good Clinical Practices, Helsinki Declaration and national regulations. The trial will be registered at the Ministry of Health.
Detailed description
Introduction. Vitamin D regulates mineral metabolism. Its deficiency has been associated with diabetes, cancer and increased mortality. 25OH vitamin D (25VD) is stable and suitable for the evaluation of vitamin D sufficiency.
The aim of the study is to evaluate whether cholecalciferol supplementation for a period of 12 weeks can normalize decreased levels of 25VD and reduce increased parathormone (iPTH) in hemodialysis (HD) patients with a vitamin D deficiency. Secondary aims: to evaluate decrease in inflammation, anemia or use of erythropoietin (epo).
Design. Randomized, double blind clinical trial in two arms of HD patients with 25VD deficiency and secondary hyperparathyroidism, one arm to be treated with cholecalciferol supplementation and the other with a placebo, for a period of 12 weeks.
Population. Patients over 18 years of age on HD for more than 3 months and levels of 25VD < 30 ng / ml and iPTH >300 ng/ml , who sign a consent form. Once their consent has been obtained, iPTH and 25VD levels will be measured. Randomization will be achieved by using a table of random numbers at the pharmacy, and neither doctors nor patients will know which group they have been assigned to.
Treatment. Supplementation will consist of three 5000 IU cholecalciferol tablets or placebo postdialysis per week during dialysis for a period of 12 weeks.
Monthly monitoring will include: haemoglobin (g/dl), Calcium (mg/dl), Phosphorous (mg/dl), iPTH (ng/ml), epo dose (IU/kg/week), epo resistance (IU/kg/week/g Hb).
At the beginning and end of the study the following will be measured: alkaline Phosphatase (IU/ml), C reactive protein (mg/L), 25VD (ng/ml), ferritin (ng/ml) and transferrin saturation, quality of life (SF36).
During the study, doses of calcitrol or paricalcitol will not be modified. The study will be discontinued if calcemia ≥ 10.5 mg/dL is detected on two occasions.
Size of sample is estimated at 120 patients for a iPTH decrease of 20% in 35% of patients in group treated (assuming 15% follow-up losses). Analysis will be done for Intention to treat for the primary outcome.
Ethical aspects: Authorization has been obtained from the Ethics Committee of the institution as regards Good Clinical Practices, Helsinki Declaration and national regulations. The trial was registered at the Ministry of Health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double blind clinical trial in two arms
| Arm | Type | Receives |
|---|---|---|
| cholecaciferol | Experimental | Drug: cholecalciferolone 5000 IU tablet of 25VD taken during dialysis (3 pills per week) for a period of 12 weeks |
| placebo | Placebo comparator | Drug: placeboone tablet of placebo taken during dialysis (3 pills per week) for a period of 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or over
- signed informed consent form
- ESRD with regular dialysis treatment for at least 3 months
- levels of 25VD < 30 ng / ml
- levels of iPTH >300 ng/ml,
Key exclusion criteria (8 listed)
- Congestive heart failure class III or IV
- unstable angina or myocardial infarction or stroke during the previous 3 months
- active malignant neoplasm
- use of any trial medication
- life expectancy lower than 6 months
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 |
|---|---|---|
| cholecalciferol | Drug | cholecaciferol |
| placebo | Drug | placebo |
Primary outcome
20 % Change in iPTH levels
Time frame: 12 weeks
20% change on final iPTH level
normalization of 25VD levels
Time frame: 12 weeks
% of patients achieving normal 25VD levels
1 secondary outcome
change of 0.5 g/dL on Hb level or 10% change in erythropoietin dose
Time frame: 12 weeks
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 27 Aug 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cholecalciferol in people with Vitamin D Deficiency and Hemodialysis Patient, run by Cooperativa Asistencia Sindicato Médico Uruguay.
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 6 inclusion and 8 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 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 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?
20 % Change in iPTH levels (time frame: 12 weeks). 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?
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 27 Aug 2018.