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

Zhejiang University logo

Zhejiang University

Status

Unknown

Conditions

Healthy

Treatments

Dietary Supplement: vitaminB12
Dietary Supplement: Fish oil

Study type

Interventional

Funder types

Other

Identifiers

NCT01762072
No.30972464

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

20 to 28 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 3 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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