This is a nationwide 6 week double blind trial using high dose zinc and B6 for the treatment of anxiety. After the completion of the 6 weeks blinded trial there will also be a further 6 weeks of open label trial to allow participants who were on placebo to try the nutrients. Participants require referral from their General Practitioner to gain access into the trial and they may not be on any psychiatric medications to be included. Participants will be screened using a generalised anxiety subjective questionnaire (GAD-7) to assess suitability for the trial. Participants will also have to meet the below inclusion and exclusion criteria.
For over 50 years clinicians, primarily orthomolecular physicians, have been treating anxiety with high dose zinc and B6 based on a urine test for a unique molecule (HPL). In this trial we will be giving high dose zinc and B6, using the urine biomarker (HPL) as a treatment predictor. The trial has been given Ethics committee and SCOTT authorisation to be performed in New Zealand.
The trial is being run by the Mental Health Research Laboratory at Canterbury University, headed by Prof/Dr. Julia Rucklidge. The Mental Health Research Laboratory is one of the foremost research laboratories, focused on the treatment of mental health conditions using nutrients.
Should you choose to refer a patient into the trial the lead researcher will keep you in contact of all progress and will refer the patient back to you at the end of the open label aspect of the trial, with recommendations and the outcomes for the patient.
Given the biochemical importance of zinc and B6 on psychological health and the possible depletion of zinc and B6 seen in individuals with elevated urinary HPL, it is possible that individuals with elevated anxiety could benefit from zinc and B6 supplementation with the degree of HPL excretion as a response predictor.
ACTIVE CONDITION INGREDIENTS LIST
What is the intervention?
| Ingredient | Quantity per capsule | Serving size | Quantity per serve |
| Zinc (as picolinate) Vitamin B6 (as pyridoxine) Vitamin B6 (as pyridoxal-5-phosphate) Also contains: Hypromellose (capsule) Maltodextrin Potato Starch Cocoa powder | 20 mg 20 mg 10 mg 150 mg 50 mg 50 mg | 5 capsules | 100 mg 100 mg 50 mg 750 mg 250 mg 250 mg |
PLACEBO CONDITION INGREDIENTS LIST
| Ingredient | Quantity per capsule | Serving size | Quantity per serve |
| Maltodextrin Potato starch Cocoa powder Hypromellose (capsule) | 400 mg 50 mg 50 mg | 5 capsules | 2000 mg 250 mg 250 mg |
The treatment condition will involve for the first 4 days, taking three capsules per day, before progressing to the full 5 capsules a day for the full 6 weeks period.
Inclusion and Exclusion criteria
Eligible participants will be:
1) females, 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
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 / breastfeeding
6) are currently taking antibiotics, altretamine (antineoplastic agent) or amiodarone (antiarrhythmic medication), (Yetley, 2007)
7) are currently taking any psychiatric medications such as antidepressants, anxiolytics, antipsychotics
8) have any major psychiatric condition or serious medical condition likely to require hospitalization (e.g. Psychotic Disorders; Bipolar Disorders).
The participants for this research will be recruited nationally throughout New Zealand by referral to the study through their GP.
To contact our researchers, please register and state that you are a GP. We will then email you further details.