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

Not Applicable

• Conditions: Healthy
• Interventions: Dietary Supplement: vitaminB12; Dietary Supplement: Fish oil

• Registration Number: NCT01762072
• Lead Sponsor: Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-01
• Study Start: 2013-01
• Study First Submitted: 2013-01-02
• Study First Submitted QC: 2013-01-03
• Last Update Submitted: 2013-01-03
• Study First Posted: 2013-01-07
• Last Update Posted: 2013-01-07
• Primary Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitaminB12	vitaminB12	VitB12 group (VitB12, n=10) receives 8 weeks of treatment with daily oral doses of 1000 μg of vitamin B12 (one capsule)
Fish oil	Fish oil	Fish oil group (FO, n=10)receives 8 weeks of treatment with daily oral doses of 2g of fish oil in the form of two capsules of fish oil) .
Fish oil+vitaminB12	Fish oil	VitB12+Fish oil group (VitB12+FO, n=10) receives 8 weeks of treatment with daily oral doses of a combination of 1000 μg of vitamin B12 and 2g of fish oil
Fish oil+vitaminB12	vitaminB12	VitB12+Fish oil group (VitB12+FO, n=10) receives 8 weeks of treatment with daily oral doses of a combination of 1000 μg of vitamin B12 and 2g of fish oil

Primary Outcome Measures

Name	Time	Method
homocysteine,umol/L	10 weeks

Trial Locations

Locations (1)

Zhejiang university; 🇨🇳 Hangzhou, Zhejiang, China