Cholecalciferol Supplementation Effect on Parathyroid Hormone in Hemodialysis Patients
Primary Purpose
Vitamin D Deficiency, Hemodialysis Patient
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
cholecalciferol
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Vitamin D Deficiency, hyperparathyroidism, hemodialysis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
cholecaciferol
placebo
Arm Description
one 5000 IU tablet of 25VD taken during dialysis (3 pills per week) for a period of 12 weeks
one tablet of placebo taken during dialysis (3 pills per week) for a period of 12 weeks
Outcomes
Primary Outcome Measures
20 % Change in iPTH levels
20% change on final iPTH level
normalization of 25VD levels
% of patients achieving normal 25VD levels
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03648528
First Posted
August 10, 2018
Last Updated
August 23, 2018
Sponsor
Cooperativa Asistencia Sindicato Médico Uruguay
1. Study Identification
Unique Protocol Identification Number
NCT03648528
Brief Title
Cholecalciferol Supplementation Effect on Parathyroid Hormone in Hemodialysis Patients
Official Title
Randomized Clinical Trial for The Evaluation of The Effects Of Cholecalciferol Supplementation On The Parathyroid Hormone In Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 15, 2015 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cooperativa Asistencia Sindicato Médico Uruguay
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Hemodialysis Patient
Keywords
Vitamin D Deficiency, hyperparathyroidism, hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double blind clinical trial in two arms
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Bottles filled with cholecalciferol or placebo pills by the drug company (Celsius) and named after randomization by the pharmacist and delivered to the dialysis unit to be administrated by the nurses
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cholecaciferol
Arm Type
Experimental
Arm Description
one 5000 IU tablet of 25VD taken during dialysis (3 pills per week) for a period of 12 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
one tablet of placebo taken during dialysis (3 pills per week) for a period of 12 weeks
Intervention Type
Drug
Intervention Name(s)
cholecalciferol
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
20 % Change in iPTH levels
Description
20% change on final iPTH level
Time Frame
12 weeks
Title
normalization of 25VD levels
Description
% of patients achieving normal 25VD levels
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
change of 0.5 g/dL on Hb level or 10% change in erythropoietin dose
Description
change of 0.5 g/dL on Hb level or 10% change in erythropoietin dose
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Learn more about this trial
Cholecalciferol Supplementation Effect on Parathyroid Hormone in Hemodialysis Patients
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