Authors
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Endeavour College of Natural Health -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2018
INTERVENTION: 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. CONDITION: Fatigue Anxiety Stress PRIMARY OUTCOME: Primary Outcome ; Stress according to the Depression Anxiety Stress Scale (DASS 21). ; SECONDARY OUTCOME: 1. Fatigue Severity Scale (FSS) ; 2. Feasibility outcomes: ; a. Recruitment ; b. Retention and adherence of participants ; 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
Epistemonikos ID: 0b88bef1abc5ae19b140800241848d2191cd7d48
First added on: Aug 24, 2024