Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00426

2 Trial Registration Date

2014-07-25

i Registration Status

Prospective

3 Secondary IDs

CRE:2014.155-T

4 Source(s) of Funding

Department of Medicine and Therapeutics

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

NA

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Hazel Mok

ii Address

Department of Medicine and Therapeutics, 9/F, Clinical Sciences Building, PWH

iii Phone

26323990

iv Email

hazelmok@cuhk.edu.hk

v Affiliation

CUHK

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Timothy Kwok

ii Address

Department of Medicine and Therapeutics, 9/F, Clinical Sciences Building, PWH

iii Phone

26323173

iv Email

tkwok@cuhk.edu.hk

v Affiliation

CUHK

vi Country

9 Official Scientific Title of the Study

An extended clinical trial of vitamin B12 supplementation to slow brain atrophy in older diabetic people with mild vitamin B12 deficiency

10 Public Title

Vitamin B12 supplement to slow brain atrophy in older diabetic outpatients

i Public Title in Chinese 研究名稱

服用維他命B12以減慢輕微維他命B12不足的老年糖尿病人的腦萎縮的延伸硏究

11 Short Title (Optional)

Vitamin B12 supplement to slow brain atrophy in older diabetic outpatients

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-04-17

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Dementia

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Vitamin B12

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

18 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Vitamin B12 for all patients

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. Age >/=70 years old
2. Caregiver (personal contact at least once a week)

ii Exclusion Criteria

Dementia

iii Age Minimum

70

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-08-15

21 Target Sample Size

175

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Whole brain volume

24 Secondary Outcome

1. Hippocampal, regional grey matter and white matter brain volume changes
2. Neurocognitive scores

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-03-31

27 Primary Registry and Trial Identifying Number

ChiCTR-OCH-14005010

28 Date of Registration in Primary Registry

2014-07-25

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

NIL

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Trial History Detail on 2014-07-29