The Effect of Methylated Vitamin B Complex on Depression
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|ClinicalTrials.gov Identifier: NCT01672372|
Recruitment Status : Completed
First Posted : August 24, 2012
Last Update Posted : August 6, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Dietary Supplement: Max Stress B Dietary Supplement: Placebo Max Stress B||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Methylated Vitamin B Complex on Depression|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
Placebo Comparator: Placebo Max Stress B
oil/water emulsion with food coloring to simulate actual product
Dietary Supplement: Placebo Max Stress B
Experimental: Max Stress B
whole-nutrient natural source extract from probiotic colonies that contains vitamins B1, B2, B5, B6, B12, and folate, PABA, biotin, inositol, purified water and certified organic alcohol.
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
- Depression level [ Time Frame: 2 months ]
Assessed by the Beck Depression Inventory II, the Beck Anxiety Inventory, SF-36v2™ Health Survey, physiological and anthropometric measures
Because item 9 of the Beck Depression Inventory inquires about "Suicidal thoughts or wishes," we will immediately notify the attending physician in the Crisis facility of UM/JMH if a subject responds affirmatively to this question, which may be indicative of suicidal ideation (SI).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672372
|United States, Florida|
|University of Miami CRB|
|Miami, Florida, United States, 33136|
|Principal Investigator:||John E Lewis, PhD||University of Miami|