UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039891 |
|---|---|
| Receipt number | R000045454 |
| Scientific Title | Native vs. active vitamin D for children with chronic kidney disease: a cross-over study |
| Date of disclosure of the study information | 2020/03/22 |
| Last modified on | 2020/03/22 22:02:51 |
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Basic information
Public title
Native vs. active vitamin D for children with chronic kidney disease: a cross-over study
Acronym
Native vs. active vitamin D for CKD children
Scientific Title
Native vs. active vitamin D for children with chronic kidney disease: a cross-over study
Scientific Title:Acronym
Native vs. active vitamin D for children with chronic kidney disease: a cross-over study: native vs. active vitamin D for CKD children
Region
| Africa |
Condition
Condition
cross-over study
Classification by specialty
| Nephrology | Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to compare native vs. active forms of vitamin D on children with CKD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mean change of 25(OH)D3 after treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
native vitamin D (cholecalciferol)
Interventions/Control_2
Active vitamin D (alfacalcidol)
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
| 3 | months-old | <= |
Age-upper limit
| 144 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
chronic kidney disease children stages 2-5 (pre-dialysis)
Key exclusion criteria
- CKD stage 5 on dialysis
- Baseline serum 25(OH)D 3level more than 30 ng/ml or baseline hypo- or hypercalcemia (serum calcium less than 8 or more than 11 mg/dl, respectively).
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Happy |
| Middle name | |
| Last name | Sawires |
Organization
Cairo University
Division name
Faculty of Medicine
Zip code
11435
Address
5 El-Lithy Streey El-Maadi Elgedida
TEL
+201005446448
happy7_kd@yahoo.com
Public contact
Name of contact person
| 1st name | Happy |
| Middle name | |
| Last name | Sawires |
Organization
Cairo University
Division name
Faculty of Medicine
Zip code
11435
Address
5 El-Lithy Streey El-Maadi Elgedida
TEL
+201005446448
Homepage URL
happy7_kd@yahoo.com
Sponsor or person
Institute
Cairo University
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Faculty of Medicine - Cairo University
Address
Kasr El-Aini Hospital, Cairo
Tel
+20223649281
happysawires@staff.cu.edu.eg
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 | 03 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
Results
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
| 2018 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 05 | Day |
Date of closure to data entry
| 2019 | Year | 11 | Month | 12 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 20 | Day |
Last modified on
| 2020 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045454
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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