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The Effect of Methylated Vitamin B Complex on Depression

NCT01672372 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-08-06

No results posted yet for this study

Summary

The proposed study is a 60-day, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of a methylated vitamin B complex nutritional supplement (Max Stress B™) for improving depressive and anxiety symptoms according to the Beck Depression and Anxiety Inventories, respectively, in 60 patients (18+ years of age) diagnosed with major depression or other forms of depressive disorders and an elevated level of homocysteine (\> 10 µmol/L) at baseline. Secondary outcomes will include anthropometrics for body composition, blood pressure and pulse, level of physical activity, dietary intake, and quality of life. Participants will be assessed at baseline and 30 and 60 days. The study will consist of two treatment arms: (a) vitamin B complex nutritional supplement and (b) placebo.

The information obtained in this study will help in determining the efficacy of using nutritional supplements for improving the outcomes of people with depression.

Conditions

Interventions

DIETARY_SUPPLEMENT

Max Stress B

Participants are to mix one vial per day of either placebo or actual supplement in 1 liter of water and drink over the course of the day

DIETARY_SUPPLEMENT

Placebo Max Stress B

Sponsors & Collaborators

  • Premier Research Labs

    collaborator OTHER

  • University of Miami

    lead OTHER

Principal Investigators

  • John E Lewis, PhD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01672372 on ClinicalTrials.gov