ClinicalTrials.gg
Status unknownNCT02005302Updated Dec 9, 2013

Optimizing Treatment Programs for Chronic Kidney Disease-mineral and Bone Disorder and Malnutrition

A Phase 4 interventional study of 1,25(OH)2 Vitamin D3 and Vitamin D2 in Vitamin D Deficiency and Malnutrition, sponsored by Wenhu Liu. Status unknown at 5 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-12-09.

Sponsored by Wenhu Liu · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2013), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 38 studies testing ergocalciferols in Vitamin D Deficiency — 1 open to participants now, 1 under way, none of them phase 3. Ergocalciferols · Vitamin D Deficiency.

Planned enrollment
Largest of 38
600 · median 64
Started
2013
with 2 others
Phase 4
12 of 38
1 open now
Registered
28th of 38
by date

Among the 38 studies testing ergocalciferols in Vitamin D Deficiency, this one has the largest planned enrollment, is one of 3 that started in 2013, is one of 12 in phase 4, and was the 28th registered.

By phase

38 studies; the count open now beside each. This study's row is marked.

No phase21 · 0 open
Phase 4this study12 · 1 open
Phase 13 · 0 open
Phase 1/21 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 2004; this study’s year is marked. 3 started in 2013.

Size and results

Median enrollment 64 across the 38 interventional studies. Of the 29 that completed or were terminated, 9 (31%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 38 studies testing ergocalciferols in Vitamin D Deficiency, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Vitamin D Deficiency
  • Malnutrition

Keywords

  • chronic kidney disease
  • mineral and bone disease
  • Malnutrition
  • Vitamin D
  • low protein diet
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Renal artery stenosis, inherent renal malformation, solitary kidney, or in urinary system.
  • Active system immunity diseases.
  • History of liver failure
  • History of intestinal malabsorption or chronic diarrhea
  • Treatment with phenobarbital, phenytoin, rifampicin, sucralfate, , digoxin, or other medications that could affect vitamin D metabolism
  • Primary hyperparathyroidism
  • 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 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 device or drug study(s); or subject is receiving another investigational agent(s).
  • Current treatment with vitamin D 50,000 IU
  • Using glucocorticoid or 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Vitamin D2 Treatment

    Drug: Vitamin D2

  • Active comparator
    1,25(OH)2 Vitamin D3

    Drug: 1,25(OH)2 Vitamin D3

  • Experimental
    low protein diet

    Dietary Supplement: low protein diet

  • Active comparator
    normal protein diet

    Dietary Supplement: normal protein diet

Interventions

  • Drug1,25(OH)2 Vitamin 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.

    Also known as: Active Vit D3

  • 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.

    Also known as: Vit D2

  • Dietary supplementlow protein diet

    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.

  • Dietary supplementnormal protein diet

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 36 months

  2. 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.

    Time frame: 36 months

Secondary outcomes

  1. The changes of the blood 25(OH)Vitamin D level

    Time frame: 36 months

  2. 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.

    Time frame: 36 months

07

Study locations

5 sites
  • Beijing XuanWu Hospital
    Beijing, Beijing 100000, China
  • People's Liberation Army Air Force General Hospital
    Beijing, Beijing 100000, China
  • People's Liberation Army General Hospital
    Beijing, Beijing 100000, China
  • Sino-Japanese Friendship Hospital
    Beijing, Beijing 100000, China
  • Beijing Friedship Hospital
    Beijing, Beijing 100050, China
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2013, a primary completion of Dec 2015 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 4, 2013
First posted
Dec 9, 2013
Start
Jan 2013
Primary completionEst.
Dec 2015
CompletionEst.
Dec 2016
Last update
Dec 9, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02005302
Lead sponsor
Wenhu Liu
Collaborators
Beijing Municipal Science & Technology Commission
Responsible party
Wenhu Liu (Professor, Beijing Friendship Hospital) — Sponsor-investigator
First posted
Dec 9, 2013
Start date
Jan 2013
Primary completion
Dec 2015 (estimated)
Completion
Dec 2016 (estimated)
Last update
Dec 9, 2013

Study contacts

Wenhu Liu, Doctor
principal investigator · Nephrology Department of Beijing Friendship Hospita

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Ergocalciferols

Start the discussion