Effect of zinc and B6 on individuals with anxiety: A double blind, randomised, placebo controlled trial.

Not Applicable

Recruiting

• Conditions: Generalized Anxiety; Social Anxiety; Mental Health - Anxiety

• Registration Number: ACTRN12619000067178
• Lead Sponsor: Dr. Julia Rucklidge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-17
• Last Update Posted: 13 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Eligible participants will be: 1) Aged 18 years and older; 2) not be on any medications for the treatment of anxiety; 3) score above 10 on the GAD-7; 4) considered reliable and compliant with the protocol.

Exclusion Criteria

Participants will be excluded if they: 1) have a history of a chronic health issue with acute attacks (e.g. advanced ulcerative colitis); 2) are known to be intolerant to nutritional supplements; 3) are known to be allergic to the ingredients of the intervention; 4) are unable to give written informed consent; 5) are pregnant; 6) are currently taking antibiotics, altretamine (antineoplastic agent) or amiodarone (antiarrhythmic medication), (Yetley, 2007), 7) any psychiatric medications such as antidepressants, anxiolytics, antipsychotics, and 8) any major psychiatric condition or serious medical condition likely to require hospitalization (e.g. Psychotic Disorders; Bipolar Disorders).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder 7-item (GAD-7) scale <br> (Spitzer, Kroenke, Williams, & Löwe, 2006)<br>[The GAD-7 will be assessed during screening, baseline and through RCT (0-42 days), 14 days, 28 days and 42 days. With baseline and 42 days being primary time points. At completion of open label (day 84) and 3, 6 and 12 months following completion of the open label phase. ];Modified Clinical Global Impressions (CGI-I) (Spearing, Post, Leverich, Brandt, & Nolen, 1997)[End of RCT (day 42) and day 42 of open label]