None listed
Conditions
Brief summary
The purpose is to investigate different nutrient formulas in the treatment of depression, stress and anxiety as a consequence of the southern Alberta flood of June 2013. The supplements we are studying are a single vitamin (vitamin D), a multi-vitamin (B complex), and a broad spectrum formula that contains both vitamins and minerals. Approximately 210 people in southern Alberta are being invited to participate in this study.
Interventions
Participants will be randomized to receive one of three nutrient formulas for six weeks: a single vitamin (Douglas Laboratories vitamin D at 1000 IU/day), a multivitamin formula (Douglas Laboratories B Complex), or a multivitamin/mineral formula (Truehope EMP). All formulas are in capsules or tablets to be consumed orally. Participants will be asked to self-monitor pill consumption and to report it every two weeks for an estimate of adherence.
Following the 6 weeks of randomization, a 6-week e
Participants will be randomized to receive one of three nutrient formulas for six weeks: a single vitamin (Douglas Laboratories vitamin D at 1000 IU/day), a multivitamin formula (Douglas Laboratories B Complex), or a multivitamin/mineral formula (Truehope EMP). All formulas are in capsules or tablets to be consumed orally. Participants will be asked to self-monitor pill consumption and to report it every two weeks for an estimate of adherence. Following the 6 weeks of randomization, a 6-week extension will be offered in which people may choose whatever formula they will to try -- either to continue with the one they have been taking, or to try one of the others. This 'personal choice extension' will not be a requirement, but for those who choose to participate, the same outcome questionnaires will be presented at the end of the extension period. Vitamin D ingredients (dose = 1/day): Vit D 25.0 mcg (1000 IU) B Complex ingredients (dose = 1/day): 3-Pyridinecarboxamide 50.0 mg Biotin 300.0 mcg Folate 400.0 mcg Intrinsic Factor 20.0 mg Pantothenic acid 50.0 mg Riboflavin 20.0 mg Thiamine 50.0 mg Vit B12 500.0 mcg Vit B6 20.0 mg Truehope EMP ingredients (dose = 4/day): l-glutamine 10.0 mg Inositol 10.0 mg Choline bitartrate 30.0 mg Phenylalanine 20.0 mg Biotin 60.0 mcg Germanium sesquioxide 1.2 mg Calciium 73.3 mg Chromium 34.7 mcg Citrus bioflavonoids 13.3 mg Copper 0.4 mg Pantothenic acid 1.2 mg Folate 80.0 mcg Ginkgo biloba 2.0 mg Iodine 11.3 mcg Iron 0.8 mg L-methionine 3.3 mg Magnesium 33.3 mg Manganese 0.5 mg Molybdenum 8.0 mcg Niacin 5.0 mg Nickel 1.6 mcg Phosphorus 46.7 mg Potassium 13.3 mg Riboflavin 0.8 mg Selenium 11.3 mcg Thiamine 1.0 mg Vanadium 66.3 mcg Vit A 96.0 mcg (320 IU) Vit B12 50.0 mcg vit B6 2.0 mg Vit C 33.3 mg Vit D 2.0 mcg (80.0 IU) Vit E 13.4 mg (20.0 IU) Vitis vinifera (grape seed) 2.5 mg Zinc 2.7 mg
Sponsors
University of Calgary
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Over 18 years of age whose homes were damaged by the Southern Alberta flood. 2. Have at least one score above the cutoffs of the Depression, Anxiety and Stress Scale, as follows: 10 (for depression), 7 (for anxiety) or 14 (for stress). 3. Free of psychiatric medications (defined as having taken none for at least four weeks)
Exclusion criteria
1. Neurological disorder involving brain or other central function (e.g., epilepsy, MS, narcolepsy), 2. Any serious medical condition, 3. Known to be allergic to the ingredients of the intervention, 4. Pregnant or breastfeeding, 5. Evidence of untreated or unstable thyroid disease, 6. Known abnormality of mineral metabolism (e.g., Wilson’s disease, haemochromatosis), 7. Reporting substance dependence within the previous month. 8. Currently participating in the Pure North health program (a local nutritional program). 9. Judged clinically to be at serious risk for suicide or violence in the opinion of the researchers (based on screening information and the intake interview).
Outcome results
None listed