Hyperhomocysteinemia Clinical Trial
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
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.
Status | Completed |
Enrollment | 390 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 60 Years to 74 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | The maternal and Children health care hospital | Yuanshi county of Shijiazhuang | Hebei |
Lead Sponsor | Collaborator |
---|---|
Peking University | Institute of reproductive and Child Health, National Natural Science Foundation of China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | folate receptor antibodies | 6 months | No | |
Other | genetic variants | 6 months | No | |
Primary | plasma homocysteine level, plasma folate acid and red blood cell folate acid, Framingham risk score | 6,12 and 18 months | No | |
Secondary | systolic blood pressure, diastolic blood pressure and hemoglobin | 6 and 12 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00005482 -
Homocyst(e)Ine, Vitamin Status, and CVD Risk
|
N/A | |
Recruiting |
NCT06264570 -
Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels.
|
N/A | |
Completed |
NCT02392767 -
Effect of L-Arginine and Pycnogenol on Light to Moderate Hypertension and Endothelial Function
|
N/A | |
Completed |
NCT02540642 -
Effect of Vitamin B12 Supplementation on Glycaemic Control in Uncontrolled Hyperhomocysteinemic Type 2 Diabetic Patients
|
N/A | |
Completed |
NCT01371357 -
The Effects of 8-week Choline, Betaine, and Folic Acid Supplementation on Plasma Homocysteine Concentration During Guanidinoacetic Acid Loading in Young Healthy Volunteers
|
Phase 3 | |
Withdrawn |
NCT01871740 -
CSPPT- Chronic Kidney Diseases Study
|
Phase 4 | |
Not yet recruiting |
NCT03720249 -
Effects of Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults With Hyperhomocysteinemia
|
N/A | |
Completed |
NCT06163443 -
Evaluating the Impact of B Vitamin Supplementation (Soloways™) on Homocysteine and LDL-C Levels in Patients With MTHFR, MTR, and MTRR Polymorphisms.
|
N/A | |
Completed |
NCT01391416 -
Prevalence Of Hyperhomocysteinemia In Thai Chronic Kidney Disease (CKD) Patients
|
N/A | |
Completed |
NCT00004495 -
Randomized Study of Folic Acid Therapy for Hyperhomocysteinemia in Patients With End Stage Renal Disease Receiving Hemodialysis
|
N/A | |
Completed |
NCT02961972 -
Effects of Oral Supplementation With Creatine on Systemic Microvascular Endothelial Function in Vegetarian Individuals
|
N/A | |
Completed |
NCT02860338 -
COMPARATIVE EFFECTIVENESS OF MCI and DEMENTIA TREATMENTS IN A COMMUNITY-BASED DEMENTIA PRACTICE
|
N/A | |
Completed |
NCT00737126 -
The Effect of Folic Acid Administration in the Progression of Microalbuminuria
|
N/A | |
Completed |
NCT00626223 -
5-methyltetrahydrofolate Survival and Inflammation in ESRD Patients
|
N/A | |
Completed |
NCT03631238 -
The Dual Impact of Homocysteine and Cholesterol on Cognitive Functions
|
||
Completed |
NCT03376490 -
Study of the Association of Muscle Strength, Balance and Other Factors With Vitamin Levels Among Elderly Diabetics
|
N/A | |
Enrolling by invitation |
NCT02817503 -
Feasibility Study of the Intensive Systolic Blood Pressure Control
|
Phase 4 | |
Completed |
NCT01766310 -
Effect of Folic Acid Supplementation on Plasma Homocysteine Level in Obese Children
|
Phase 4 | |
Completed |
NCT00005483 -
Plasma Homocysteine Distribution in the United States
|
N/A | |
Completed |
NCT00473200 -
Effect of S-adenosylmethionine (SAMe) on Blood Levels of Homocysteine
|
Phase 1 |