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NCT01762072 Clinical Trial

Effect of Vitamin B12 and n-3 Polyunsaturated Fatty Acids on Plasma Homocysteine

Healthy Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01762072
Other study ID # No.30972464
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 2, 2013
Last updated January 3, 2013
Start date January 2013

Study information
Verified date January 2013
Source Zhejiang University
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Vitamin B12and n-3 polyunsaturated fatty acids (PUFA) decrease blood homocysteine (Hcy) concentration. However, the combined effect of these nutrients on Hcy and ferritin, and C-reactive protein is limited and inconclusive. The objective was to examine the synergistic effect of vitamin B12 in combination of n-3 PUFA on plasma Hcy, ferritin, and other biochemical markers. In a randomized controlled trial, thirty eligible subjects were randomly divided into three groups, and assigned to receive 1000 μg of vitamin B12, 2g fish oil, or 1000 μg vitamin B12 and 2g fish oil respectively for 8 weeks. Plasma phospholipid (PL) fatty acids and biochemical markers were determined. we hypothesize that combination of vitamin B12 and fish oil have synergistic effect on lowering plasma concentrations of Hcy and ferritin.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 28 Years
Eligibility Inclusion Criteria:

- reliability, regular eating habits, normal weight, nondrinking, and nonsmoking status

Exclusion Criteria:

- None of the selected subjects used any vitamins or dietary supplements and was taking no medication for at least 8 weeks before the start of and during the entire experimental period

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Fish oil

• vitaminB12

Locations
Country Name City State
China Zhejiang university Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary homocysteine,umol/L 10 weeks No
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