UMIN-CTR Clinical Trial

Public title

Study of fall prevention by vitamin D in the elderly

Acronym

Fall prevention study by vitamin D in the elderly

Scientific Title

Study of fall prevention by vitamin D in the elderly

Scientific Title:Acronym

Fall prevention study by vitamin D in the elderly

Region

Japan

Condition

Patients attending the outpatient clinic at Kyorin University Hospital or other facilities participating in this project, who are at or over the age of 65 years; who have an experience of falling within one year; and whose creatinine clearance is less than 65ml/min by the Cockcroft-Gault formulas

Classification by specialty

Geriatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Vitamin D is reported to prevent falling not only from improving osteoporosis but also from other factors such as increasing muscle strength and decreasing body sway. Since this is reported outside from Japan, we will test the possibility of preventing falls by vitamin D in the Japanese population.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Frequency of falls after 6 months and 1 year

Key secondary outcomes

Bone mineral density, bone metabolism markers, neuropsychological function, Fall-related factors such as muscle strength, fall-predicting score

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Term: one year Drug: vitamin D (one alpha) Dose: 0.5 ug/day Frequency: every morning

Interventions/Control_2

Term: one year Drug: precipitated calcium carbonate (caltan) Dose: 500 mg/day Frequency: every morning

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

65

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients at or over the age of 65 years, who are attending Kyorin University Hospital or other facilities participating in this project, who have a history of falling within one year, and whose creatinine clearance is less than 65mL/min by the Cockcroft-Gault formulas. All subjects or their family must give a written informed consent, especially in case of demented patients.

Key exclusion criteria

1. Bed-ridden patient 2. Patient who has severe liver, GI-tract, or heart disease 3. Parkinson's disease 4. User of a wheel-chair 5. Patient who has paralysis 6. Patient who have a past history of treatment with vitamin D within 6 months 7. Inflammatory degenerative joint disease such as rheumatoid arthritis or osteoarthritis 8. Demented patient who is unable to evaluate a history of falling 9. Patient who has a past history of hypercalcemia or urolithiasis 10. Ineligible patient determined by the attending doctor

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Kenji Toba

Organization

Kyorin University School of Medicine

Division name

Department of Geriatric Medicine

Zip code

Address

6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan

TEL

0422-47-5511

Email

Name of contact person

1st name
Middle name
Last name	Koichi Kozaki

Organization

Kyorin University School of Medicine

Division name

Department of Geriatric Medicine

Zip code

Address

6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan

TEL

0422-44-1917

Homepage URL

Email

kozaki-tky@umin.ac.jp

Institute

Department of Geriatric Medicine, Kyorin University School of Medicine

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Date of protocol fixation

2006

Year

12

Month

18

Day

Date of IRB

Anticipated trial start date

2009

Year

04

Month

01

Day

Last follow-up date

2012

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

03

Month

31

Day

Last modified on

2009

Year

03

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001882