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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Zhejiang University
Sponsor:
Information provided by (Responsible Party):
Tao Huang, Zhejiang University
ClinicalTrials.gov Identifier:
NCT01762072
First received: January 2, 2013
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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 Intervention
Healthy
Dietary Supplement: Fish oil
Dietary Supplement: vitaminB12

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Zhejiang University:

Primary Outcome Measures:
  • homocysteine,umol/L [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 28 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762072

Locations
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
  More Information

No publications provided

Responsible Party: Tao Huang, postdoctoral researcher, Zhejiang University
ClinicalTrials.gov Identifier: NCT01762072     History of Changes
Other Study ID Numbers: No.30972464
Study First Received: January 2, 2013
Last Updated: January 3, 2013
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014