A Study of Fixed Dose Versus Serum Level-Based Titration Regimen of Vitamin D Supplementation in Dialysis Patients

February 6, 2024 updated by: Piyawan Kittiskulnam, Chulalongkorn University

A Randomized Study Comparing Between Fixed Dose and Serum Level-Based Titration Regimen of Vitamin D Supplementation Among Dialysis Patients

Vitamin D insufficiency, defined as serum 25-hydroxyvitamin (OH) D level less than 30 ng/ml, is highly prevalent not only in the general population but also in chronic kidney disease (CKD) population. Many guidelines including the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) have consistently recommended vitamin D supplementation in patients with pre-dialysis CKD with vitamin D insufficiency with ergocalciferol or cholecalciferol to achieve 25(OH)D level of more than 30 ng/ml using serum levels-based titration regimen. However, this protocol has not been studied in end stage kidney disease patients treated with maintenance dialysis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators plan to conduct a randomized study comparing the two different protocols between serum 25(OH)D level-based titration regimen and fixed dose of ergocalciferol supplementation among dialysis patients for a total period of 6 months. At the study completion, investigators also plan to compare the proportion of participants achieving serum 25(OH)D of more than 30 ng/ml, CKD-related metabolic and bone parameters as well as non-skeletal effect of vitamin D supplementation for each group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Chulalongkorn Univeristy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age > 18 years
  • on maintenance dialysis (hemodialysis or peritoneal dialysis) > 3 months
  • 25(OH)D < 30 ng/ml
  • able to provide inform consent form

Exclusion Criteria:

  • current ergocalciferol or cholecalciferol treatment
  • known allergy to ergocalciferol
  • active inflammation or infection
  • advanced stage of cancer
  • pregnancy
  • lactation
  • on immunosuppressive drugs or corticosteroids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Vitamin D supplementation using titration regimen

Patients will receive ergocalciferol orally depending on serum 25(OH)D level as described

  • serum 25(OH)D < 5 ng/ml --> receive ergocalciferol 50,000 IU/week for 3 months followed by 50,000 IU monthly for 3 months
  • serum 25(OH)D 5-15 ng/ml--> receive ergocalciferol 50,000 IU/week for 1 month followed by 50,000 IU monthly for 5 months
  • serum 25(OH)D 16-30 ng/ml--> receive ergocalciferol 50,000 IU monthly for 6 months
Other: ergocalciferol supplementation
Participants in both groups will recieve ergocalciferol with different supplementation regimens for 6 months.
Other Names:
  • nutritional vitamin D supplementation
Other: dialysis techniques
Both groups will have participants treated with maintenance hemodialysis and peritoneal dialysis.
Other Names:
  • mode of dialysis
Other: sunlight exposure time
Both groups will be advised to receive similar hours of daily sunlight exposure time.
Experimental: Vitamin D supplementation using fixed dose regimen
Patients will receive ergocalciferol 20,000 unit orally per week for 6 months.
Other: ergocalciferol supplementation
Participants in both groups will recieve ergocalciferol with different supplementation regimens for 6 months.
Other Names:
  • nutritional vitamin D supplementation
Other: dialysis techniques
Both groups will have participants treated with maintenance hemodialysis and peritoneal dialysis.
Other Names:
  • mode of dialysis
Other: sunlight exposure time
Both groups will be advised to receive similar hours of daily sunlight exposure time.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
proportion of patients with vitamin D adequacy
Time Frame: 6 months
serum 25(OH)D more than 30 ng/ml
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
serum calcium
Time Frame: 6 months
pre-dialysis serum calcium levels
6 months
serum phosphorus
Time Frame: 6 months
pre-dialysis serum phosphorus levels
6 months
serum intact parathyroid hormone
Time Frame: 6 months
pre-dialysis serum intact parathyroid hormone levels
6 months
muscle mass
Time Frame: 6 months
bioimpedance-derived muscle mass measurement
6 months
muscle strength
Time Frame: 6 months
handgrip strength measurement
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chulalongkorn University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Piyawan Kittiskulnam, Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 326/65

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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