None listed
Conditions
Brief summary
Vitamin supplement use is prevalent in Australia. B-vitamin supplements have been shown to reduce symptoms associated with stress and anxiety, and new 'activated' B vitamins are claimed to achieve this clinical outcome with greater efficiency. However, despite the increased costs, there are no clinical data to support this health claim. Tertiary students are at high risk of increased stress. This randomised control trial will compare the effectiveness of activated B-complex vitamins against standard-B-complex vitamins on stress, fatigue and anxiety outcomes in tertiary students. Participants will be recruited from the Sydney campus of Endeavour College of Natural Health and randomly assigned to one of two groups; 1.Activated-B or 2.Standard-B. The study duration will be four weeks, including a pre-treatment week and baseline data collection and treatment for three weeks. The primary outcome measure will be the validated instrument DASS 21; secondary outcomes will include the Fatigue Severity Scale and feasbility markers; recruitment, retention and adherence of participants.
Interventions
Interventions will include using activated-B-Vitamin complex as the comparator and standard B-vitamin complex as the active control.
Standard B-Vitamin "Mega B complex" - Active control
Listed with the Therapeutic Goods Administration Aust L 196115.
Description: Herbs of Gold Mega B Complex contains therapeutic amounts of all B vitamins including B1, B2, B3, B5, B6, B12, biotin and folic acid, as well as choline and inositol (Herbs of Gold, 2017).
Ingredients: Each Capsule contains; Biotin 100
Interventions will include using activated-B-Vitamin complex as the comparator and standard B-vitamin complex as the active control. Standard B-Vitamin "Mega B complex" - Active control Listed with the Therapeutic Goods Administration Aust L 196115. Description: Herbs of Gold Mega B Complex contains therapeutic amounts of all B vitamins including B1, B2, B3, B5, B6, B12, biotin and folic acid, as well as choline and inositol (Herbs of Gold, 2017). Ingredients: Each Capsule contains; Biotin 100micrograms, Calcium pantothenate 75mg, Choline bitartrate 50mg, Cyanocobalamin 500 micrograms, folic acid 500 micrograms, Inositol 50mg, Nicotinamide 100mg, Nicotinic acid 10mg, pyridoxine hydrochloride 100mg, Riboflavin 100mg, Thiamine hydrochloride 100mg "Activated B-vitamin Complex" - Comparator Listed with the Therapeutic Goods Administration Aust L 284123. Description: Herbs of Gold Activated B Complex contains activated B vitamins, including B2, B6, methyl-folate (folate) and mecobalamin (B12), to help support healthy energy levels and assist in the maintenance of general wellbeing (Herbs of Gold, 2017). Ingredients: Each tablet contains Calcium pantothenate 25mg, levomefolate calcium 433.1 microgram, mecobalamin (co-methylcobalamin) 400 microgram, Nicotinamide 25mg, pyridoxal 5-phosphate monohydrate 25mg, Riboflavin sodium phosphate 25mg, Thiamine hydrochloride 25mg. Washout period details – Trial in its entirely will be conducted over a four-week period. This will include a one-week wash out period and a three-week intervention period. Dosage for both Activated B-vitamin and Standard B-vitamin will be 1 capsule or tablet respectively, daily with food over a 3 week period (21 days). Participants do have currently access to both interventions as they are widely available for sale in health food shops and pharmacy. Participants will be provided with the interventions for free during the trial period. Participants will continue to have access to both vitamins activated and standard post trial. Adherence: Adherence will be observed through study personnel. All supplements will be return at the conclusion of the 3 weeks and tablets counted to assess adherence.
Sponsors
Endeavour College of Natural Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Caregiver, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
A student enrolled at Endeavour College of Natural Health Sydney campus Aged over 18 years Willing to abstain from vitamins regime for one week Time availability to attend two one-hour data collection session
Exclusion criteria
Pregnancy Known allergies to B group vitamins Not willing to abstain from vitamins regime for one week
Outcome results
None listed