None listed
Conditions
Brief summary
Anxiety related disorders are found in 7.3% of the population worldwide. Anxiety is the body’s natural response to stress and can include feelings of excessive nervousness, fear, apprehension, and worry. Traditional treatments for anxiety include psychological therapies and pharmacological drugs, both of which have shown good efficacy. However, these treatments have limitations including side effects and access. One approach which is gaining international attention is treating psychiatric symptoms with nutrients. Two nutrients in particular, zinc and vitamin B6, may have potential as a treatment for anxiety but have yet to be adequately tested. This clinical trial aims to test the efficacy of these nutrients using a randomized controlled trial (RCT). The RCT will compare micronutrient supplementation of zinc and vitamin B6 versus a placebo supplementation in the treatment of anxiety. One hundred and twenty participants with high anxiety will take part in this 6 week RCT followed by a 6 week open label extension. A urine biomarker, known as hydroxyhemoppyrrole-2-one (HPL), and believed to be associated with depletions in zinc and B6, will be measured before and after exposure to the micronutrients/placebo to determine whether higher levels predict response to the intervention. Elevated HPL (commonly referred to as pyroluria) has been observed in individuals with mental health disorders and it has been suggested that the molecule binds and combines with zinc and vitamin B6.
Interventions
Dose of intervention is 100 mg of zinc and 100 mg of vitamin B6 as pyrodoxine and 50 mg of vitamin B6 as P5P.
Duration of intervention is 6 weeks.
Mode of administration is an oral tablet.
Participants will be required to return any unused supplements as a measure of adherence.
The same participants (both placebo and treatment) will then be offered treatment for a further 6 weeks in an open label phase of the study. The duration between phases will be 7 days.
During open label participants wi
Dose of intervention is 100 mg of zinc and 100 mg of vitamin B6 as pyrodoxine and 50 mg of vitamin B6 as P5P. Duration of intervention is 6 weeks. Mode of administration is an oral tablet. Participants will be required to return any unused supplements as a measure of adherence. The same participants (both placebo and treatment) will then be offered treatment for a further 6 weeks in an open label phase of the study. The duration between phases will be 7 days. During open label participants will be offered dose of is 100 mg of zinc and 100 mg of vitamin B6 as pyrodoxine and 50 mg of vitamin B6 as P5P. Duration of open label is 6 weeks. Mode of administration is an oral tablet. Participants will be required to return any unused supplements as a measure of adherence.
Sponsors
Dr. Julia Rucklidge
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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).
Outcome results
None listed