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

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ClinicalTrials.gov Identifier: NCT01762072
Recruitment Status : Unknown
Verified January 2013 by Tao Huang, Zhejiang University.
Recruitment status was:  Not yet recruiting
First Posted : January 7, 2013
Last Update Posted : January 7, 2013
Information provided by (Responsible Party):
Tao Huang, 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.

Condition or disease Intervention/treatment
Healthy Dietary Supplement: Fish oil Dietary Supplement: vitaminB12

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Study Start Date : January 2013
Estimated Primary Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: vitaminB12
VitB12 group (VitB12, n=10) receives 8 weeks of treatment with daily oral doses of 1000 μg of vitamin B12 (one capsule)
Dietary Supplement: vitaminB12
Experimental: 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) .
Dietary Supplement: Fish oil
Experimental: 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
Dietary Supplement: Fish oil Dietary Supplement: vitaminB12

Primary Outcome Measures :
  1. homocysteine,umol/L [ Time Frame: 10 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 28 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762072

China, Zhejiang
Zhejiang university Not yet recruiting
Hangzhou, Zhejiang, China, 310029
Contact: Duo Li, PhD    86-571-88982024    duoli@zju.edu.cn   
Sponsors and Collaborators
Zhejiang University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tao Huang, postdoctoral researcher, Zhejiang University
ClinicalTrials.gov Identifier: NCT01762072     History of Changes
Other Study ID Numbers: No.30972464
First Posted: January 7, 2013    Key Record Dates
Last Update Posted: January 7, 2013
Last Verified: January 2013

Keywords provided by Tao Huang, Zhejiang University:
homocysteine-vitamin B12-fish oil-ferritin

Additional relevant MeSH terms:
Vitamin B 12
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs