Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00373

2 Trial Registration Date

2013-07-04

i Registration Status

Prospective

3 Secondary IDs

CRE_2012.175-T

4 Source(s) of Funding

RGC

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

NIL

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, PWH

iii Phone

2632 3990

iv Email

hazelmok@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

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

i Name

Prof. Timothy Kwok

ii Address

Department of Medicine and Therapeutics, PWH

iii Phone

2632 3145

iv Email

tkwok@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

The use of B vitamins to prevent cognitive decline in older mild cognitive impairment patients with elevated plasma homocysteine – A randomized placebo controlled trial

10 Public Title

The use of B vitamins to prevent cognitive decline in older mild cognitive impairment patients with elevated plasma homocysteine – A randomized placebo controlled trial

i Public Title in Chinese 研究名稱

服用維他命B為有輕度認知障礙和高〝同型半胱氨酸〞血漿水平的長者預防智力衰退 - 安慰劑隨機抽樣對照臨床研究

11 Short Title (Optional)

NA

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?

2012-06-06

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 and Folic acid

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

24 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Vitamin B12 and Folic acid in intervention group. Placebo in control group

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. Clinical diagnosis of MCI
3. Homocysteine ≥ 13µmol/L
4. Caregiver (personal contact at least once a week)

ii Exclusion Criteria

1. Demenita
2. Hypothyroidism
3. B12 < 150 pmol/L
4. Folate < 9.5 nmol/L
5. Creatinine > 200 µmol/L

iii Age Minimum

70

iv Age Maximum

NIL

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2013-08-01

21 Target Sample Size

336

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Cognitive improvement (CDR score)

24 Secondary Outcome

CDR sum of scores, neurocognitive test, depression scale

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

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

NIL

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Trial History Detail on 2013-07-04