UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000029944
Receipt number	R000034180
Scientific Title	Distribution of serum zinc levels and supplementary effect of zinc acetate in chronic kidney disease (CKD) and hemodialysis (HD) patients.
Date of disclosure of the study information	2017/11/14
Last modified on	2018/11/13 09:58:46

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Basic information

Public title

Distribution of serum zinc levels and supplementary effect of zinc acetate in chronic kidney disease (CKD) and hemodialysis (HD) patients.

Acronym

Prevalence of hypozincemia and effect of zinc in CKD and HD patients

Scientific Title

Distribution of serum zinc levels and supplementary effect of zinc acetate in chronic kidney disease (CKD) and hemodialysis (HD) patients.

Scientific Title:Acronym

Prevalence of hypozincemia and effect of zinc in CKD and HD patients

Region

Japan

Condition

CKD and HD patients
CKD and HD patients with hypozincemia

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To investigate the prevalence of hypozincemia in CKD and HD patients in our hospital.
To determine the patients' background, serum chemistries, and drug prescription related with hypozincemia.
To verify the supplementary effect of zinc acetate (NOBELZIN) with a questionnaire for clinical symptoms in the patients with hypozincemia.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Assessment

Primary outcomes

Serum zinc levels at baseline and at a few months after the zinc acetate-treatment started in the patients diagnosed as hypozincemia

Key secondary outcomes

1. Other serum chemistries
2. Questionnaire for clinical symptoms (only in zinc acetate-prescribed patients)
3. Prescription of other drugs

Base

Study type

Interventional

Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Daily oral administration of zinc acetate (NOBELZIN, 25-50 mg/time, b.i.d. or t.i.d. for a few months)

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

CKD and HD patients diagnosed as zinc deficiency (serum zinc level < 60 micro g/dL) or latent zinc deficiency (60-80 micro g/dL)

Key exclusion criteria

1. Patients without informed consent
2. Patients with poor drug adherence
3. Patients judged inappropriate by physicians

Target sample size

300

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Nobuo Nagano

Organization

Hidaka Hospital, Hidaka-kai

Division name

Kidney Disease and Dialysis Center

Zip code

Address

886, Nakao-machi, Takasaki-shi, Gunma 370-0001, JAPAN

TEL

027-362-6201

Email

n_nagano@hidaka-kai.com

Public contact

Name of contact person

1st name

Middle name

Last name Nobuo Nagano

Organization

Hidaka Hospital, Hidaka-kai

Division name

Kidney Disease and Dialysis Center

Zip code

Address

886, Nakao-machi, Takasaki-shi, Gunma 370-0001, JAPAN

TEL

027-362-6201

Homepage URL

Email

n_nagano@hidaka-kai.com

Sponsor or person

Institute

Hidaka Hospital and Heisei Hidaka Clinic, Hidaka-kai

Institute

Department

Personal name

Funding Source

Organization

Hidaka Hospital, Hidaka-kai

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2017 Year 11 Month 14 Day

Related information

URL releasing protocol

Publication of results

Partially published

Result

URL related to results and publications

Number of participants that the trial has enrolled

Results

<CKD patients>
The mean serum zinc level was 61.0 micro-g/dL of 54 CKD patients in our hospital. There were no relationships between serum zinc levels and gender, age, DM or blood sampling time. Serum zinc levels positively correlated with BMI, Alb, TG, uncorrected Ca, Hb and UIBC, and negatively correlated with BUN and ESA-RI. A multiple regression analysis showed that Alb, Hb and ESA-RI were significant independent predictors of the serum zinc levels. In patients with hypozincemia, there were more patients with nephrotic syndrome, advanced CKD and ESA treatment. In addition, BMI, Alb, TG, eGFR, non-corrected Ca, Hb and UIBC were lower, and BUN, Cr and ESA-RI were higher in patients with hypozincemia. Furthermore, there were no differences in serum iron levels, TSAT and UIBC between the patients with and without hypozincemia. As a result of binomial logistic regression analysis, only Hb was chosen as an independent factor predicting hypozincemia. Serum zinc levels did not correlate with iron levels. Lastly, ESA-RI negatively correlated with serum zinc levels but not with markers of iron metabolism (serum iron levels, TSAT, and ferritin).

<Hemodialysis Patients>
The median serum zinc level was 59 micro-g/dL of 518 hemodialysis patients in our dialysis center. The serum zinc levels were not related with age, sex, BMI, DM, or dialysis time slot, but positively correlated with dialysis vintage. In addition, serum zinc levels were lower in HDF patients than those in HD patients. Multiple regression analysis showed that dialysis vintage, Cr, Na, TG, Alb, ALP and Ht were significant independent predictors of the serum zinc levels. The proportion of patients with serum zinc levels less than 60 micro-g /dL was 51.0%. Binomial logistic regression analysis showed that HDF therapy, P, Alb and ALP were significant independent predictors of hypozincemia. On the other hand, serum zinc levels were not correlated with ESA dosage, ESA resistance index, or the use of other drugs.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 10 Month 12 Day

Date of IRB

Anticipated trial start date

2017 Year 10 Month 27 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Publication:
Jpn J Nephrol 2018; 60: 609-618.
J Jpn Soc Dial Nephrol 2018; 51(6): 369-377.

Management information

Registered date

2017 Year 11 Month 13 Day

Last modified on

2018 Year 11 Month 13 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034180

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name