Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cholecalciferol Supplementation Effect on Parathyroid Hormone in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648528
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Laura Sola, Cooperativa Asistencia Sindicato Médico Uruguay

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.


Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Hemodialysis Patient Drug: cholecalciferol Drug: placebo Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double blind clinical trial in two arms
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial for The Evaluation of The Effects Of Cholecalciferol Supplementation On The Parathyroid Hormone In Hemodialysis Patients
Actual Study Start Date : October 15, 2015
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: cholecaciferol
one 5000 IU tablet of 25VD taken during dialysis (3 pills per week) for a period of 12 weeks
Drug: cholecalciferol
Placebo Comparator: placebo
one tablet of placebo taken during dialysis (3 pills per week) for a period of 12 weeks
Drug: placebo



Primary Outcome Measures :
  1. 20 % Change in iPTH levels [ Time Frame: 12 weeks ]
    20% change on final iPTH level

  2. normalization of 25VD levels [ Time Frame: 12 weeks ]
    % of patients achieving normal 25VD levels


Secondary Outcome Measures :
  1. change of 0.5 g/dL on Hb level or 10% change in erythropoietin dose [ Time Frame: 12 weeks ]
    change of 0.5 g/dL on Hb level or 10% change in erythropoietin dose



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Study Documents (Full-Text)

Documents provided by Laura Sola, Cooperativa Asistencia Sindicato Médico Uruguay:
Study Protocol  [PDF] December 7, 2015
Informed Consent Form  [PDF] December 7, 2015


Layout table for additonal information
Responsible Party: Laura Sola, Principal Investigator, Cooperativa Asistencia Sindicato Médico Uruguay
ClinicalTrials.gov Identifier: NCT03648528    
Other Study ID Numbers: 2014/004
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018

Layout table for additional information
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
Keywords provided by Laura Sola, Cooperativa Asistencia Sindicato Médico Uruguay:
Vitamin D Deficiency
hyperparathyroidism
hemodialysis
Additional relevant MeSH terms:
Layout table for MeSH terms
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Hormones
Parathyroid Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents