None listed
Conditions
Brief summary
The purpose of this study is to evaluate the effectiveness of a micronutrient supplement in the treatment of depressive symptoms, for non-responders to the initial probiotic intervention in a previous trial. This micronutrient formula (Daily Essential Nutrients; and it's predecessor EMPowerplus) has proven efficacy for mood in trials on many different subjects, from people suffering with stress post earthquake, to people with ADHD, and more. The aim of this research study is to ascertain whether the supplement is effective in improving symptoms of depression, in people who have not responded to previous treatment.
Interventions
Open label trial using a micronutrient formula called Daily Essential Nutrients, made by Hardy Nutritionals. The key ingredients of this micronutrient formula include Vitamin A (as retinyl palmitate) 1920IU, Vitamin C (as ascorbic acid) 200mg, Vitamin D (as cholecalciferol) 1000IU, Vitamin E (as d-alpha tocopheryl succinate) 120IU, Vitamin K (as phylloquinone and menaquinone-7) 40mcg, Thiamin (as thiamin mononitrate) 20mg, Riboflavin 6mg, Niacin (as niacinamide) 30mg, Vitamin B6 (as pyridoxine h
Open label trial using a micronutrient formula called Daily Essential Nutrients, made by Hardy Nutritionals. The key ingredients of this micronutrient formula include Vitamin A (as retinyl palmitate) 1920IU, Vitamin C (as ascorbic acid) 200mg, Vitamin D (as cholecalciferol) 1000IU, Vitamin E (as d-alpha tocopheryl succinate) 120IU, Vitamin K (as phylloquinone and menaquinone-7) 40mcg, Thiamin (as thiamin mononitrate) 20mg, Riboflavin 6mg, Niacin (as niacinamide) 30mg, Vitamin B6 (as pyridoxine hydrochloride) 23.3mcg, Folic acid (50% as L-methylfolate calcium) 500mcg, Vitamin B12 (as methylcobalamin) 300mcg, Biotin 360mcg, Pantothenic acid (as d-calcium pantothenate) 10mg, Calcium (as chelate) 440mg, Iron (as chelate) 4.6mg, Phosphorus (as chelate) 280mg, Iodine (from Pacific kelp) 68mcg, Magnesium (as chelate) 200mg, Zinc (as chelate) 16mg, Selenium (as chelate) 68mcg, Copper (as chelate) 2.4mg, Manganese (as chelate) 3.2mg, Chromium (as chelate) 208mcg, Molybdenum (as chelate) 48mcg, and Potassium (as chelate) 80mg. More detailed information, as well as a full ingredient list for the product, can be obtained from the manufacturer's website - http://www.hardynutritionals.com . The intervention requires the oral intake of 15 capsules per day (in 3 doses of 5, mid meal), for 8 weeks. Participants will be asked to record any doses missed as well as any unusual events in their life, in a study diary.
Sponsors
Julia Rucklidge
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Must have been a participant in a previous study: An intervention using probiotics for depressive symptoms (Trial ID ACTRN12613000438752). Must be a "non-responder" to the probiotic treatment after the open label phase. A response is classified as >50% change on MADRS (primary outcome measure). Must have a MADRS score of >19 (moderate depression) at beginning of trial.
Exclusion criteria
Identical to exclusion criteria for probiotic trial, as no new participants will be recruited (Trial ID ACTRN12613000438752). Neurological disorder involving brain or other central function (e.g., epilepsy, MS, narcolepsy). Any serious medical condition for which major medical interventions are anticipated during the duration of the trial. Any patient known to be allergic to the ingredients of the intervention. Pregnancy or breastfeeding. Any other medication with primarily central nervous system activity, including mood stabilizers. Participants must have been off of these medications for a minimum of four weeks prior to the trial. Patients will be excluded temporarily if they have taken an oral antibiotic in the previous 6 weeks. If an antibiotic is begun during the course of the trial, that patient will be withdrawn from the study. Any subject judged clinically to be at serious risk for suicide or violence in the opinion of the researchers. Participants will be asked to minimize their intake of colas, tea, coffee, alcohol, cigarettes and illicit drugs. These substances will be monitored as part of the trial. Participants will be excluded if they take any antidepressant herbal supplement, including St John’s Wort and 5-HTP. Renal, hepatic, cardiovascular and respiratory diseases Any person whose immune system is known to be weakened (e.g. by HIV/AIDS, a genetic defect, long-term use of corticosteroids or taking immunosuppressive medications).
Outcome results
None listed