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

NCT ID: NCT01762072

Last Updated: 2013-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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vitaminB12

VitB12 group (VitB12, n=10) receives 8 weeks of treatment with daily oral doses of 1000 μg of vitamin B12 (one capsule)

Group Type PLACEBO_COMPARATOR

vitaminB12

Intervention Type DIETARY_SUPPLEMENT

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) .

Group Type EXPERIMENTAL

Fish oil

Intervention Type DIETARY_SUPPLEMENT

Fish oil+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

Group Type EXPERIMENTAL

Fish oil

Intervention Type DIETARY_SUPPLEMENT

vitaminB12

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Fish oil

Intervention Type DIETARY_SUPPLEMENT

vitaminB12

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Tao Huang

postdoctoral researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhejiang university

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Facility Contacts

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Duo Li, PhD

Role: primary

86-571-88982024

References

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Huang T, Li K, Asimi S, Chen Q, Li D. Effect of vitamin B-12 and n-3 polyunsaturated fatty acids on plasma homocysteine, ferritin, C-reaction protein, and other cardiovascular risk factors: a randomized controlled trial. Asia Pac J Clin Nutr. 2015;24(3):403-11. doi: 10.6133/apjcn.2015.24.3.19.

Reference Type DERIVED
PMID: 26420180 (View on PubMed)

Other Identifiers

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No.30972464

Identifier Type: -

Identifier Source: org_study_id

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