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Effects of Low-dose Complex B-vitamins on Homocysteine and Framingham Risk Score Among Chinese Elderly

Primary Purpose

Hyperhomocysteinemia

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Low-dose complex B-vitamins
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperhomocysteinemia focused on measuring homocysteine, folate acid,, vitamin B, random controlled trail

Eligibility Criteria

60 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male and female residents living in the field site for at least 12 months
  • Aged 60-74 years

Exclusion Criteria:

  • History of chronic disease and taking medications for treatment such as CVD, COPD, cancer, severe renal and liver disease, diabetes.
  • Use of multivitamins, and individual vitamins such as folic acid, B12, or B6 in the last 6 months.
  • Taking medications known to interfere with folate metabolism, including methotrexate, tamoxifen, L-DOPA, niacin, phenytoin, bile acid sequestrants; anticonvulsant medications (such as dilantin, phenytoin, and primidone), Metformin, Sulfasalazine.
  • Conditions that prevent participation or compliance such as Downs syndrome, mental problems, or severe cognitive impairment

Sites / Locations

  • The maternal and Children health care hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Low-dose complex B-vitamins

Vitamin C

Arm Description

Intervention group receives Low-dose complex B-vitamins every day. Low-dose complex B-vitamins contain 400µg of folic acid, 2mg of vitamin B6, 10µg of vitamin B12 and 50mg vitamin C. Daily supplementation lasts for 12 months

Control group receives Vitamin C (50mg)every day. Daily supplementation lasts for 12 months.

Outcomes

Primary Outcome Measures

plasma homocysteine level, plasma folate acid and red blood cell folate acid, Framingham risk score

Secondary Outcome Measures

systolic blood pressure, diastolic blood pressure and hemoglobin

Full Information

First Posted
September 18, 2008
Last Updated
June 4, 2015
Sponsor
Peking University
Collaborators
Institute of reproductive and Child Health, National Natural Science Foundation of China
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1. Study Identification

Unique Protocol Identification Number
NCT00755664
Brief Title
Effects of Low-dose Complex B-vitamins on Homocysteine and Framingham Risk Score Among Chinese Elderly
Official Title
Effects of Low-dose B-vitamins Supplementation on Plasma Homocysteine and Framingham Risk Score: Double Blind Randomized Controlled Trial in Healthy Chinese Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
Collaborators
Institute of reproductive and Child Health, National Natural Science Foundation of China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate whether low dose complex B-vitamins (folic acid,vitamin B6 and vitamin B12) can lower the risk of developing hyperhomocysteinemia in an apparently healthy population with low folate/B12 and high Hcy status.
Detailed Description
Hyperhomocysteinemia has been well known as an independent risk factor for CVD. Numerous studies have demonstrated that certain kinds of vitamin B(folic acid,vitamin B6 and vitamin B12)can reduce Hcy level and may prevent CVD. However, the majority of those studies has been conducted always used high dose vitamin in patient or high risk population. There is thus absence of data that the effectiveness of low dose complex B-vitamins on the apparently Chinese elderly population with relative sub-nutritional status. Our study is just focus on the aforementioned aspect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhomocysteinemia
Keywords
homocysteine, folate acid,, vitamin B, random controlled trail

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
390 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-dose complex B-vitamins
Arm Type
Active Comparator
Arm Description
Intervention group receives Low-dose complex B-vitamins every day. Low-dose complex B-vitamins contain 400µg of folic acid, 2mg of vitamin B6, 10µg of vitamin B12 and 50mg vitamin C. Daily supplementation lasts for 12 months
Arm Title
Vitamin C
Arm Type
Placebo Comparator
Arm Description
Control group receives Vitamin C (50mg)every day. Daily supplementation lasts for 12 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Low-dose complex B-vitamins
Other Intervention Name(s)
vitamin supplement
Intervention Description
The complex B vitamins supplement has been made as capsule and packaging 31 capsules in 1 bottle with a pre-determined code number on its cover. The main content contains either vitamin C 50mg alone or combination with folate 0.4 mg, vitamin B6 2mg, vitamin B12 10μg and vitamin C 50 mg. Two kinds of the supplements could not be discriminated by appearance, smell, taste, size and package.volunteers in either arms are required to take 1 capsule per day and last for 48 weeks.
Primary Outcome Measure Information:
Title
plasma homocysteine level, plasma folate acid and red blood cell folate acid, Framingham risk score
Time Frame
6,12 and 18 months
Secondary Outcome Measure Information:
Title
systolic blood pressure, diastolic blood pressure and hemoglobin
Time Frame
6 and 12 months
Other Pre-specified Outcome Measures:
Title
folate receptor antibodies
Time Frame
6 months
Title
genetic variants
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female residents living in the field site for at least 12 months Aged 60-74 years Exclusion Criteria: History of chronic disease and taking medications for treatment such as CVD, COPD, cancer, severe renal and liver disease, diabetes. Use of multivitamins, and individual vitamins such as folic acid, B12, or B6 in the last 6 months. Taking medications known to interfere with folate metabolism, including methotrexate, tamoxifen, L-DOPA, niacin, phenytoin, bile acid sequestrants; anticonvulsant medications (such as dilantin, phenytoin, and primidone), Metformin, Sulfasalazine. Conditions that prevent participation or compliance such as Downs syndrome, mental problems, or severe cognitive impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianmeng Liu, Prof.
Organizational Affiliation
Institute of reproductive and Child health, PUHSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
The maternal and Children health care hospital
City
Yuanshi county of Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China

12. IPD Sharing Statement

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Effects of Low-dose Complex B-vitamins on Homocysteine and Framingham Risk Score Among Chinese Elderly

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