Vitamin D DeficiencyPhase 4NCT02005302
Optimizing Treatment Programs for Chronic Kidney Disease-mineral and Bone Disorder and Malnutrition
A Phase 4 study testing 1,25(OH)2 Vitamin D3, Vitamin D2 and low protein diet in people with Vitamin D Deficiency and Malnutrition, run by Wenhu Liu at 5 sites in China.
Trial summary
Multi-center, prospective, randomized, controlled study to verify the clinical effectiveness of K / DOQI guidelines. The efficiency and safety of Vitamin D2 and low protein diet treatment for prevention and treatment of CKD-MBD and malnutrition in CKD3-5 (ND) patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vitamin D Deficiency, Malnutrition
- What is being tested?
- 1,25(OH)2 Vitamin D3, Vitamin D2 and low protein diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 5 sitesChina
- Study dates
- Jan 2013to Dec 2016
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with age between 18-80 years.
- Patients with chronic kidney disease stage 3 to 5, and concurrent chronic kidney disease mineral and bone disorder and malnutrition
Who cannot join
- Renal artery stenosis, inherent renal malformation, solitary kidney, or malignancy in urinary system.
- Active system immunity diseases.
- History of liver failure
- History of intestinal malabsorption or chronic diarrhea
- Treatment with phenobarbital, phenytoin, rifampicin, sucralfate, steroids, digoxin, or other medications that could affect vitamin D metabolism
- Primary hyperparathyroidism
Show all 17Show fewer
- Treatment with cinacalcet or other calcimimetic within the past 6 months
- Anticipated dialysis within 6 months after randomization
- Have an unstable medical condition, defined as having been hospitalized within 30 days before screening, the expectation of recurrent hospital admissions or life expectancy of less than 6 months in the judgment of the investigator
- Subject is currently enrolled in, or fewer than 30 days have passed since subject has completed another investigational device or drug study(s); or subject is receiving another investigational agent(s).
- Current treatment with vitamin D 50,000 IU
- Using glucocorticoid or immunosuppressive agents.
- Acute renal dysfunction.
- The expected live time is less than 2 years.
- Pregnant or lactating woman.
- Suffered from acute myocardial infraction, acute congestive heart failure, or stroke in last 6 months.
- Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Beijing XuanWu Hospital
Beijing, Beijing Municipality, 100000
People's Liberation Army Air Force General Hospital
Beijing, Beijing Municipality, 100000
People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100000
Sino-Japanese Friendship Hospital
Beijing, Beijing Municipality, 100000
Beijing Friedship Hospital
Beijing, Beijing Municipality, 100050
About this study
Official title: Study of Vitamin D2 Virus 1,25(OH)2-Vitamin D3 and Normal Protein Diet Virus Low Protein Diet in the Treatment of CKD-MBD and Malnutrition for Progressive CKD Patients
Multi-center, prospective, randomized, controlled study to verify the clinical effectiveness of K / DOQI guidelines. The efficiency and safety of Vitamin D2 and low protein diet treatment for prevention and treatment of CKD-MBD and malnutrition in CKD3-5 (ND) patients.
Read the detailed description
This study will enroll chronic kidney disease patients, stage 3 to 5ND, who have chronic kidney disease mineral and bone disease (CKD-MBD) and malnutrition as defined by Kidney Disease Improvement Global Outcome (KDIGO) Guidelines. Patients in five centers will be randomized. A total of 600 patients will be enrolled, 150 patients receiving Vitamin D2 treatment virus 150 patients receiving calcitriol treatment, and another 150 patients receiving low protein diet virus 150 patients receiving normal protein diet. Outcomes will be assessed as proportion of patients achieving target blood levels on calcium, phosphorus, parathyroid hormone, 25 hydroxyvitamin D, albumin and hemoglobin. Other outcomes will also be assessed, which include secondary hyperparathyroidism (sHPT), vascular calcification, cardiovascular diseases, nutritional status and quality of life.
- Conditions
- Vitamin D Deficiency, Malnutrition
- Being tested
- 1,25(OH)2 Vitamin D3, Vitamin D2, low protein diet, normal protein diet
- Keywords
- chronic kidney disease, mineral and bone disease, Malnutrition, Vitamin D, low protein diet
- Medical subject headings
- Vitamin D Deficiency, Malnutrition, Renal Insufficiency, Chronic, Calcinosis, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1,25(OH)2 Vitamin D3Drug
Also called Active Vit D3
Oral 1,25(OH)2 Vitamin D3 by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
Vitamin D2Drug
Also called Vit D2
Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
low protein dietDietary supplement
Using nutritious software to make meals recipes and give dietary guidance for patients to reach the DPI goal of 0.6g-0.8g/kg/d.
normal protein dietDietary supplement
Using nutritious software to make meals recipes and give dietary guidance for patients to reach the DPI goal of more than 0.8g/kg/d.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D2 Treatment | Experimental | Not described Receives: Drug: Vitamin D2 |
| 1,25(OH)2 Vitamin D3 | Active comparator | Not described Receives: Drug: 1,25(OH)2 Vitamin D3 |
| low protein diet | Experimental | Not described Receives: Dietary Supplement: low protein diet |
| normal protein diet | Active comparator | Not described Receives: Dietary Supplement: normal protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes on the blood levels of calcium, phosphorus, and intact parathyroid (iPTH) hormone during 36 months
The blood levels of calcium, phosphorus,and intact parathyroid (iPTH) will be detected every three months. The values during follow-up will be compared to the baseline.
Measured: 36 months
The changes on the clinical indicators of nutritional status
The blood levels of albumin, prealbumin, transferrin and hemoglobin will be detected every three months. The values during follow-up will be compared to the baseline.
Measured: 36 months
Secondary outcomes (2)
The changes of the blood 25(OH)Vitamin D level
Measured: 36 months
The changes of the quality of life
Assess the quality of life for patients in accordance with KDQOL-SF scale every 6 month. The values during follow-up will be compared to the baseline.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenhu Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Responsible party
- Sponsor-investigator, Wenhu Liu, Beijing Friendship Hospital
- Investigators
- Wenhu Liu, Doctor, Principal investigator, Nephrology Department of Beijing Friendship Hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005302
- Sponsor's protocol ID
- BJFH-EC/2013-076
- Other IDs
- D131100004713001
- Status last verified
- Dec 2013
- First submitted
- 4 Dec 2013
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Vitamin D2 Virus 1,25(OH)2-Vitamin D3 and Normal Protein Diet Virus Low Protein Diet in the Treatment of CKD-MBD and Malnutrition for Progressive CKD Patients
- ClinicalTrials.gov ID
- NCT02005302
- Acronym / sponsor ID
- BJFH-EC/2013-076
- Conditions
- Vitamin D Deficiency, Malnutrition
- Keywords
- chronic kidney disease, mineral and bone disease, Malnutrition, Vitamin D, low protein diet
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Wenhu LiuUniversity, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Dec 2013 (estimated)
- 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.
Multi-center, prospective, randomized, controlled study to verify the clinical effectiveness of K / DOQI guidelines. The efficiency and safety of Vitamin D2 and low protein diet treatment for prevention and treatment of CKD-MBD and malnutrition in CKD3-5 (ND) patients.
Detailed description
This study will enroll chronic kidney disease patients, stage 3 to 5ND, who have chronic kidney disease mineral and bone disease (CKD-MBD) and malnutrition as defined by Kidney Disease Improvement Global Outcome (KDIGO) Guidelines. Patients in five centers will be randomized. A total of 600 patients will be enrolled, 150 patients receiving Vitamin D2 treatment virus 150 patients receiving calcitriol treatment, and another 150 patients receiving low protein diet virus 150 patients receiving normal protein diet. Outcomes will be assessed as proportion of patients achieving target blood levels on calcium, phosphorus, parathyroid hormone, 25 hydroxyvitamin D, albumin and hemoglobin. Other outcomes will also be assessed, which include secondary hyperparathyroidism (sHPT), vascular calcification, cardiovascular diseases, nutritional status and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin D2 Treatment | Experimental | Drug: Vitamin D2 |
| 1,25(OH)2 Vitamin D3 | Active comparator | Drug: 1,25(OH)2 Vitamin D3 |
| low protein diet | Experimental | Dietary Supplement: low protein diet |
| normal protein diet | Active comparator | Dietary Supplement: normal protein diet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with age between 18-80 years.
- Patients with chronic kidney disease stage 3 to 5, and concurrent chronic kidney disease mineral and bone disorder and malnutrition
Key exclusion criteria (17 listed)
- Renal artery stenosis, inherent renal malformation, solitary kidney, or malignancy in urinary system.
- Active system immunity diseases.
- History of liver failure
- History of intestinal malabsorption or chronic diarrhea
- Treatment with phenobarbital, phenytoin, rifampicin, sucralfate, steroids, digoxin, or other medications that could affect vitamin D metabolism
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 |
|---|---|---|
| 1,25(OH)2 Vitamin D3Also: Active Vit D3Oral 1,25(OH)2 Vitamin D3 by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone. | Drug | 1,25(OH)2 Vitamin D3 |
| Vitamin D2Also: Vit D2Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level. | Drug | Vitamin D2 Treatment |
| low protein dietUsing nutritious software to make meals recipes and give dietary guidance for patients to reach the DPI goal of 0.6g-0.8g/kg/d. | Dietary supplement | low protein diet |
| normal protein dietUsing nutritious software to make meals recipes and give dietary guidance for patients to reach the DPI goal of more than 0.8g/kg/d. | Dietary supplement | normal protein diet |
Primary outcome
The changes on the blood levels of calcium, phosphorus, and intact parathyroid (iPTH) hormone during 36 months
Time frame: 36 months
The blood levels of calcium, phosphorus,and intact parathyroid (iPTH) will be detected every three months. The values during follow-up will be compared to the baseline.
The changes on the clinical indicators of nutritional status
Time frame: 36 months
The blood levels of albumin, prealbumin, transferrin and hemoglobin will be detected every three months. The values during follow-up will be compared to the baseline.
2 secondary outcomes
The changes of the blood 25(OH)Vitamin D level
Time frame: 36 months
The changes of the quality of life
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
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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.
Wenhu Liu, Doctor principal investigator
Nephrology Department of Beijing Friendship Hospita
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1,25(OH)2 Vitamin D3, Vitamin D2 and low protein diet in people with Vitamin D Deficiency and Malnutrition, run by Wenhu Liu at 5 sites in China.
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 2 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The changes on the blood levels of calcium, phosphorus, and intact parathyroid (iPTH) hormone during 36 months (time frame: 36 months). The study lists 2 primary outcomes in all. 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 9 Dec 2013.