Cholecalciferol Supplementation Effect on Parathyroid Hormone in Hemodialysis Patients

NCT03648528 | Completed Phase 4

• 1 other identifier: 2014/004
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vitamin D Deficiency; Hemodialysis Patient

Keywords

Vitamin D Deficiency; hyperparathyroidism; hemodialysis

Outcome Measures

Primary Outcomes (2)

• 20 % Change in iPTH levels

  20% change on final iPTH level

  12 weeks

• normalization of 25VD levels

  % of patients achieving normal 25VD levels

  12 weeks

Secondary Outcomes (1)

• change of 0.5 g/dL on Hb level or 10% change in erythropoietin dose

  12 weeks

Study Arms (2)

cholecaciferol

EXPERIMENTAL

one 5000 IU tablet of 25VD taken during dialysis (3 pills per week) for a period of 12 weeks

Drug: cholecalciferol

placebo

PLACEBO COMPARATOR

one tablet of placebo taken during dialysis (3 pills per week) for a period of 12 weeks

Drug: placebo

Interventions

cholecalciferol DRUG

cholecaciferol

placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cooperativa Asistencia Sindicato Médico Uruguay: lead

MeSH Terms

Conditions

Vitamin D Deficiency; Hyperparathyroidism

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, double blind clinical trial in two arms

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 27, 2018
• Study Start: October 15, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: August 27, 2018

Record last verified: 2018-08