UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of nutritional vitamin D supplements in hemodialysis patients
Title of the study (Brief title)	Nutritional vitamin D supplementation in hemodialysis patients
Region	Japan

Condition
Condition	CKD-5D
Classification by specialty	Medicine in general Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the serum 25(OH)D level in hemodialysis patients. Additionally, to assess the effects of supplementation in hemodialysis patients with nutritional vitamin D.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Serum 25(OH)D and 1,25(OH)2D levels at 6 and 12 months after the beginning of supplementation of nutritional vitamin D.
Key secondary outcomes	Serum calcium, phosphorus, albumin, and intact parathyroid hormone levels, CRP(C-reactive protein) levels, Serum fibroblast growth factor 23 (FGF 23)levels, hemoglobin (Hb) levels, changes in blood pressure, medication use (erythrocyte-stimulating agents, activated vitamin D)

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	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Ingestion of ergocalciferol (vitamin D2, which comes from plant sources), 400 IU daily for 6 months of the first half, and continue to take it at the same dose for 6 months of the latter half.
Interventions/Control_2	Ingestion of ergocalciferol (vitamin D2, which comes from plant sources), 400 IU daily for 6 months of the first half, and continue to take it at the same dose, additionally oral cholecalciferol (vitamin D3, which comes from animal sources), 7000 IU weekly for 6 months of the latter half.
Interventions/Control_3	Control group
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	1. hemodialysis patients 2. Subjects who agree to participate in the current study with a written informed consent
Key exclusion criteria	1. Subjects who are at risk of having allergic reactions to drugs or supplements 2. Subjects who regularly take nutritional vitamin D
Target sample size	40

Research contact person
Name of lead principal investigator	Masanori Okamoto
Organization	Saiseikai Wakayama Hospital
Division name	Kidney Center
Address	12 banchou 45, Wakaya, Japan
TEL	073-424-5185
Email	mokamoto@wakayama-med.ac.jp

Public contact
Name of contact person	Masanori Okamoto
Organization	Saiseikai Wakayama Hospital
Division name	Kidney Center
Address	12 banchou, Wakayama, Japan
TEL	073-424-5185
Homepage URL
Email	mokamoto@wakayama-med.ac.jp

Sponsor
Institute	Saiseikai Wakayama Hospital
Institute
Department

Funding Source
Organization	Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Division of Nephrology, Wakayama Medical University, Japan

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	2015 Year 12 Month 31 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 08 Month 01 Day
Anticipated trial start date	2015 Year 08 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 31 Day
Last modified on	2017 Year 03 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023557