UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039034 |
|---|---|
| Receipt number | R000044513 |
| Scientific Title | The impact of zinc levels on nutritional status in hemodialysis patients |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2025/07/03 13:23:56 |
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Basic information
Public title
The impact of zinc levels on nutritional status
Acronym
Zinc levels and nutrition
Scientific Title
The impact of zinc levels on nutritional status in hemodialysis patients
Scientific Title:Acronym
Zinc levels and nutritional status in hemodialysis patients
Region
| Japan |
Condition
Condition
Zinc deficiency
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the association between zinc levels and nutritional status
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle mass, fat mass and bone mineral content at the beginning of study and after 12 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Medicine |
Interventions/Control_1
Taking zinc 25-100mg/day orally
Interventions/Control_2
Not taking zinc
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients with zinc deficiency
Key exclusion criteria
Hemodialysis patients without zinc deficiency
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Fukasawa |
Organization
Iwata City Hospital
Division name
Renal Division
Zip code
438-0083
Address
512-3 Ohkubo, Iwata, Shizuoka
TEL
0538-38-5000
hfukasawaucsd@gmail.com
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Fukasawa |
Organization
Iwata City Hospital
Division name
Renal Division
Zip code
438-0083
Address
512-3 Ohkubo, Iwata, Shizuoka
TEL
0538-38-5000
Homepage URL
hfukasawaucsd@gmail.com
Sponsor or person
Institute
Renal Division, Iwata City Hospital
Institute
Department
Personal name
Funding Source
Organization
Iwata City Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwata City Hospital
Address
512-3 Ohkubo, Iwata, Shizuoka
Tel
0538-38-5000
hfukasawaucsd@gmail.com
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 | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/1744-9987.14218?af=R
Publication of results
Partially published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/1744-9987.14218?af=R
Number of participants that the trial has enrolled
80
Results
Serum zinc levels were significantly correlated with body fat weight
(p < 0.01), but not with nonfat tissue weight. Multiple regression analyses
demonstrated that serum zinc levels were a significant independent predictor
of body fat weight (p < 0.001). Furthermore, the weight of body fat significantly
increased in the group that received 1-year zinc supplementation
(p < 0.05), but not in the group that did not.
Results date posted
| 2025 | Year | 07 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
80 patients undergoing maintenance hemodialysis at Iwata City Hospital.
Participant flow
We conducted an open-label randomized controlled trial. We investigated
(i) the relationship between serum zinc levels and body composition
and (ii) the effects of zinc supplementation on the composition of 48 HD
patients with zinc deficiency.
Adverse events
None
Outcome measures
We investigated
(i) the relationship between serum zinc levels and body composition
and (ii) the effects of zinc supplementation on the composition of 48 HD
patients with zinc deficiency.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 30 | Day |
Last modified on
| 2025 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044513
