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NCT01672372 · ClinicalTrials.gov registry record · NA
The Effect of Methylated Vitamin B Complex on Depression
A NA study, sponsored by University of Miami.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT01672372 is a NA study that has completed, run by University of Miami. The registered enrollment target is 60 participants.
The verdict
NCT01672372, a NA study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
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.
Interventions
- DIETARY_SUPPLEMENT Max Stress B
- DIETARY_SUPPLEMENT Placebo Max Stress B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-01 |
| Est. Completion | 2011-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01672372
The ClinicalTrials.gov registry entry for NCT01672372 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Max Stress B is the first listed.
NCT01672372 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01672372 about?
NCT01672372 is a clinical study titled "The Effect of Methylated Vitamin B Complex on Depression". 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, i...
What is the current status of trial NCT01672372?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2011-01. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01672372?
The interventions under investigation include: Max Stress B (DIETARY_SUPPLEMENT), Placebo Max Stress B (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01672372?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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