UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039214
Receipt number R000044691
Scientific Title Relationship between sarcopenia, nutritional index and dietary intake in elderly dialysis patients
Date of disclosure of the study information 2020/01/21
Last modified on 2023/07/26 15:38:09

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Basic information

Public title

Relationship between sarcopenia, nutritional index and dietary intake in elderly dialysis patients

Acronym

Relationship between sarcopenia, nutritional index and dietary intake in elderly dialysis patients

Scientific Title

Relationship between sarcopenia, nutritional index and dietary intake in elderly dialysis patients

Scientific Title:Acronym

Relationship between sarcopenia, nutritional index and dietary intake in elderly dialysis patients

Region

Japan


Condition

Condition

Hemodialysis

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the relationship between sarcopenia and nutritional indicators and dietary intake status of elderly hemodialysis patients

Basic objectives2

Others

Basic objectives -Others

Provide nutritional intervention for patients with sarcopenia.
Review sarcopenia every year.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1.Sarcopenia
2.Food intake status
3.Nutrition index

Evaluation at the beginning of the study, every year, and at the end of the study

Key secondary outcomes

1.Laboratory test values
2.Body component analysis
3.Grip strength,5CS


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Nutrition intervention for sarcopenia group to achieve 7/10 or more based on food intake diversity score (DVS)

Interventions/Control_2

Regular practice

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Outpatient hemodialysis patients aged 65 and over
2.Patients with sarcopenia

Key exclusion criteria

1.Patients who have difficulty communicating
2.Patients who cannot diagnose sarcopenia

Target sample size

100


Research contact person

Name of lead principal investigator

1st name kana
Middle name
Last name iwasa

Organization

Kawashima-kai, a social medical corporation Kawashima Hospital

Division name

Nutrition management room

Zip code

770-0011

Address

1-39 Kitasako Ichibancho, Tokushima City, Tokushima Prefecture

TEL

088-631-0110

Email

k.iwasa@khg.or.jp


Public contact

Name of contact person

1st name kana
Middle name
Last name iwasa

Organization

Kawashima-kai, a social medical corporation Kawashima Hospital

Division name

Nutrition management room

Zip code

770-0011

Address

1-39 Kitasako Ichibancho, Tokushima City, Tokushima Prefecture

TEL

088-631-0110

Homepage URL


Email

k.iwasa@khg.or.jp


Sponsor or person

Institute

Kawashima-kai, a social medical corporation Kawashima Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kawashima-kai, a social medical corporation Kawashima Hospital

Address

1-39 Kitasako Ichibancho, Tokushima City, Tokushima Prefecture

Tel

088-631-0110

Email

k.iwasa@khg.or.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 01 Month 21 Day


Related information

URL releasing protocol

https://center6.umin.ac.jp/cgi-bin/icdr/ctr_menu_form_reg.cgi?recptno=R000044691

Publication of results

Published


Result

URL related to results and publications

https://center6.umin.ac.jp/cgi-bin/icdr/ctr_menu_form_reg.cgi?recptno=R000044691

Number of participants that the trial has enrolled

68

Results

Elderly patients with sarcopenia had adequate protein intake but low SMI.

It was suggested that nutritional screening by GNRI and NRI-JH is necessary in addition to protein intake in nutritional guidance for elderly patients.

The sarcopenia group had a significantly lower BMI and no weight gain or loss over the past 5 years, suggesting the need for nutritional guidance to prevent underweight.

Results date posted

2023 Year 07 Month 26 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Outpatient hemodialysis patients aged 65 years or older with dialysis history of 2 years or longer (42 males, 26 females)

Participant flow

Evaluation of sarcopenia: Extremity muscle mass, grip strength, five-time chair rise test by bioelectrical impedance method (Inbody Japan Co., Ltd. InbodyS10)
Nutrition index: GNRI (Geriatric Nutritional Risk Index), NRI-JH (nutritional risk index for Japanese hemodialysis patients)
Dietary intake status: Calculation of intake and number of meals for each nutrient and food group based on meal records for 3 days (1 day for dialysis, 2 days for non-dialysis)
  Required nutrients are calculated by standard weight (kg) x physical activity (kcal)

Adverse events

none

Outcome measures

Evaluation of sarcopenia: Extremity muscle mass, grip strength, five-time chair rise test by bioelectrical impedance method (Inbody Japan Co., Ltd. InbodyS10)
Nutrition index: GNRI (Geriatric Nutritional Risk Index), NRI-JH (nutritional risk index for Japanese hemodialysis patients)
Dietary intake status: Calculation of intake and number of meals for each nutrient and food group based on meal records for 3 days (1 day for dialysis, 2 days for non-dialysis)
  Required nutrients are calculated by standard weight (kg) x physical activity (kcal)

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 12 Month 25 Day

Date of IRB

2020 Year 01 Month 07 Day

Anticipated trial start date

2020 Year 02 Month 01 Day

Last follow-up date

2022 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2022 Year 07 Month 29 Day


Other

Other related information



Management information

Registered date

2020 Year 01 Month 21 Day

Last modified on

2023 Year 07 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044691


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name