NCT00755664

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2007

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

5.2 years

First QC Date

September 18, 2008

Last Update Submit

June 4, 2015

Conditions

Hyperhomocysteinemia

Keywords

homocysteinefolate acid,vitamin Brandom controlled trail

Outcome Measures

Primary Outcomes (1)

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

    6,12 and 18 months

Secondary Outcomes (1)

  • systolic blood pressure, diastolic blood pressure and hemoglobin

    6 and 12 months

Other Outcomes (2)

  • folate receptor antibodies

    6 months

  • genetic variants

    6 months

Study Arms (2)

Low-dose complex B-vitamins

ACTIVE COMPARATOR

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

Dietary Supplement: Low-dose complex B-vitamins

Vitamin C

PLACEBO COMPARATOR

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

Dietary Supplement: Low-dose complex B-vitamins

Interventions

Low-dose complex B-vitaminsDIETARY_SUPPLEMENT

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.

Also known as: vitamin supplement
Low-dose complex B-vitaminsVitamin C

Eligibility Criteria

Age60 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The maternal and Children health care hospital

Yuanshi County of Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Hyperhomocysteinemia

Condition Hierarchy (Ancestors)

Amino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMalabsorption SyndromesMetabolic DiseasesNutritional and Metabolic DiseasesVitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Study Officials

  • Jianmeng Liu, Prof.

    Institute of reproductive and Child health, PUHSC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Institute of reproductive and Child Health

Study Record Dates

First Submitted

September 18, 2008

First Posted

September 19, 2008

Study Start

July 1, 2007

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

CN(1)