Effect of Vitamin B12 and n-3 Polyunsaturated Fatty Acids on Plasma Homocysteine
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 2, 2013
CompletedFirst Posted
Study publicly available on registry
January 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedJanuary 7, 2013
January 1, 2013
2 months
January 2, 2013
January 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
homocysteine,umol/L
10 weeks
Study Arms (3)
vitaminB12
PLACEBO COMPARATORVitB12 group (VitB12, n=10) receives 8 weeks of treatment with daily oral doses of 1000 μg of vitamin B12 (one capsule)
Fish oil
EXPERIMENTALFish 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
EXPERIMENTALVitB12+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
Interventions
Eligibility Criteria
You may qualify if:
- reliability, regular eating habits, normal weight, nondrinking, and nonsmoking status
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhejiang university
Hangzhou, Zhejiang, 310029, China
Related Publications (1)
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.
PMID: 26420180DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- postdoctoral researcher
Study Record Dates
First Submitted
January 2, 2013
First Posted
January 7, 2013
Study Start
January 1, 2013
Primary Completion
March 1, 2013
Last Updated
January 7, 2013
Record last verified: 2013-01