Effect of Vitamin B12 and n-3 Polyunsaturated Fatty Acids on Plasma Homocysteine
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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 |
- 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 |
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| China, Zhejiang | |
| Zhejiang university | Not yet recruiting |
| Hangzhou, Zhejiang, China, 310029 | |
| Contact: Duo Li, PhD 86-571-88982024 duoli@zju.edu.cn | |
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 May 16, 2013