Vitamin D DeficiencyNCT05434377
A Study of Fixed Dose Versus Serum Level-Based Titration Regimen of Vitamin D Supplementation in Dialysis Patients
A study testing ergocalciferol supplementation, dialysis techniques and sunlight exposure time in people with Vitamin D Deficiency and End Stage Renal Disease, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Vitamin D Deficiency, End Stage Renal Disease
- What is being tested?
- ergocalciferol supplementation, dialysis techniques and sunlight exposure time
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteThailand
- Study dates
- 1 Aug 2022to 31 Dec 2023
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- on maintenance dialysis (hemodialysis or peritoneal dialysis) > 3 months
- 25(OH)D < 30 ng/ml
- able to provide inform consent form
Who cannot join
- current ergocalciferol or cholecalciferol treatment
- known allergy to ergocalciferol
- active inflammation or infection
- advanced stage of cancer
- pregnancy
- lactation
- on immunosuppressive drugs or corticosteroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vitamin D Deficiency, End Stage Renal Disease
- Being tested
- ergocalciferol supplementation, dialysis techniques, sunlight exposure time
- Keywords
- vitamin D insufficiency, dialysis, ergocalciferol
- Medical subject headings
- Vitamin D Deficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ergocalciferol supplementationOther
Also called nutritional vitamin D supplementation
Participants in both groups will recieve ergocalciferol with different supplementation regimens for 6 months.
dialysis techniquesOther
Also called mode of dialysis
Both groups will have participants treated with maintenance hemodialysis and peritoneal dialysis.
sunlight exposure timeOther
Both groups will be advised to receive similar hours of daily sunlight exposure time.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D supplementation using titration regimen | Active comparator | 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 Receives: Other: ergocalciferol supplementation; Other: dialysis techniques; Other: sunlight exposure time |
| Vitamin D supplementation using fixed dose regimen | Experimental | Patients will receive ergocalciferol 20,000 unit orally per week for 6 months. Receives: Other: ergocalciferol supplementation; Other: dialysis techniques; Other: sunlight exposure time |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with vitamin D adequacy
serum 25(OH)D more than 30 ng/ml
Measured: 6 months
Secondary outcomes (5)
serum calcium
pre-dialysis serum calcium levels
Measured: 6 months
serum phosphorus
pre-dialysis serum phosphorus levels
Measured: 6 months
serum intact parathyroid hormone
pre-dialysis serum intact parathyroid hormone levels
Measured: 6 months
muscle mass
bioimpedance-derived muscle mass measurement
Measured: 6 months
muscle strength
handgrip strength measurement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Aug 2022
- Primary completion31 May 2023
- Study completion31 Dec 2023
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.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piyawan Kittiskulnam, Chulalongkorn University
- Investigators
- Piyawan Kittiskulnam, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434377
- Sponsor's protocol ID
- 326/65
- Status last verified
- Feb 2024
- First submitted
- 21 Jun 2022
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Comparing Between Fixed Dose and Serum Level-Based Titration Regimen of Vitamin D Supplementation Among Dialysis Patients
- ClinicalTrials.gov ID
- NCT05434377
- Acronym / sponsor ID
- 326/65
- Conditions
- Vitamin D Deficiency, End Stage Renal Disease
- Keywords
- vitamin D insufficiency, dialysis, ergocalciferol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 28 Jun 2022 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D supplementation using titration regimen | Active comparator | Other: ergocalciferol supplementation, Other: dialysis techniques, Other: sunlight exposure timePatients 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 |
| Vitamin D supplementation using fixed dose regimen | Experimental | Other: ergocalciferol supplementation, Other: dialysis techniques, Other: sunlight exposure timePatients will receive ergocalciferol 20,000 unit orally per week for 6 months. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > 18 years
- on maintenance dialysis (hemodialysis or peritoneal dialysis) > 3 months
- 25(OH)D < 30 ng/ml
- able to provide inform consent form
Key exclusion criteria (7 listed)
- current ergocalciferol or cholecalciferol treatment
- known allergy to ergocalciferol
- active inflammation or infection
- advanced stage of cancer
- pregnancy
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 |
|---|---|---|
| ergocalciferol supplementationAlso: nutritional vitamin D supplementationParticipants in both groups will recieve ergocalciferol with different supplementation regimens for 6 months. | Other | Vitamin D supplementation using fixed dose regimen, Vitamin D supplementation using titration regimen |
| dialysis techniquesAlso: mode of dialysisBoth groups will have participants treated with maintenance hemodialysis and peritoneal dialysis. | Other | Vitamin D supplementation using fixed dose regimen, Vitamin D supplementation using titration regimen |
| sunlight exposure timeBoth groups will be advised to receive similar hours of daily sunlight exposure time. | Other | Vitamin D supplementation using fixed dose regimen, Vitamin D supplementation using titration regimen |
Primary outcome
proportion of patients with vitamin D adequacy
Time frame: 6 months
serum 25(OH)D more than 30 ng/ml
5 secondary outcomes
serum calcium
Time frame: 6 months
serum phosphorus
Time frame: 6 months
serum intact parathyroid hormone
Time frame: 6 months
muscle mass
Time frame: 6 months
muscle strength
Time frame: 6 months
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 8 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Vitamin D Deficiency
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
RecruitingObservational study
A Natural History Study of Bone and Mineral Disorders
Tumor Induced Osteomalcia, Osteomalacia
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Active, not recruiting
Preeclampsia Research on Vitamin D, Inflammation, & Depression
Pre-Eclampsia, Depression
Not yet recruiting
The Effectiveness of a Weight-dependent Algorithm for Dosing Vitamin D.
Hypovitaminosis D
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.
Piyawan Kittiskulnam principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ergocalciferol supplementation, dialysis techniques and sunlight exposure time in people with Vitamin D Deficiency and End Stage Renal Disease, run by Chulalongkorn University at 1 site in Thailand.
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 4 inclusion and 7 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 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
proportion of patients with vitamin D adequacy (time frame: 6 months). 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 8 Feb 2024.