None listed
Conditions
Interventions
Intervention1: LS/24-25/Vit001: One capsule twice a day after main meal for 90 days.
Control Intervention1: Placebo: One capsule twice a day after main meal for 90 days.
Sponsors
Life Synergy
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women aged 18 years or older who follow a vegetarian, vegan diet 2. Present serum vitamin B12 levels of 148 to 221 pmol per L [201 to 300 pg per mL]) and with or without symptoms associated with vitamin B12 deficiency 3. Sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Present diagnosed diseases that may interfere with vitamin B12 markers, including gastrointestinal diseases (such as inflammatory bowel disease, celiac disease, ileal resection, Crohns disease, constipation or atrophic gastritis), pancreatic diseases, kidney diseases, liver diseases, diabetes, cardiovascular diseases, pernicious anemia and cancer 2. Medical history of abdominal surgery that may influence the absorption of vitamin B12 (such as bariatric surgery) 3. Being on hemodialysis treatment 4. Present values of body mass index less than or equal to 18.5 kg per meter square or greater than or equal to 35 kg per meter square 5. Having consumed or consuming vitamin B12 or folate supplements for more than 2 months before inclusion in the study 6. Have taken medications that affect the absorption and therapeutic response of vitamin B12 (such as methotrexate, metformin, proton pump inhibitors, H2 receptor antagonists, histamine, nitrous oxide, colchicine, neomycin, biguanides, cholestyramine, aminosalicylic acid, chloramphenicol and other bone marrow depressants) one month before inclusion in the study 7. Participants with known systemic and metabolic diseases in the investigators discretion not proving fit for trial 8. Known hypersensitivity to investigational products 9. Participants currently taking any of the following supplements for health maintenance or benefits: multivitamin mineral (MVM), B vitamins, fish oil, Ayurvedic or herbal supplements, nutraceutical supplements, fiber supplements, glucosamine or chondroitin probiotics, iron supplements, or protein powders 10. Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study 11. Any prescribed medication except for oral contraceptives (not acceptable if oral contraceptives are used to disrupt normal or monthly menstrual cycle) includes recent antibiotic and or oral corticosteroid use 12. Donated blood within two months before study entry, and must not donate blood during the study duration 13. Serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude the successful completion of the study 14. Have participated in any investigational therapeutic trial within the past 1 year that the investigator feels would influence or affect the outcome of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in vitamin B12 levels 2. Changes in State-Trait Anxiety Inventory score 3. Changes in Fatigue severity scale score 4. Assessment of energy audit diary 5. Changes in Health Organization Quality of Life (WHOQOL BREF) questionnaire scoreTimepoint: 1. Screening, day 30, day 60 and day 90 2. Screening, day 30, day 60 and day 90 3. Screening, day 30, day 60 and day 90 4. Day 1, day 30, day 60 and day 90 5. Screening and day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events profile 2. Compliance and tolerability of the investigational productTimepoint: 1. Baseline, day 30, day 60 and day 90 2. Screening, day 30, day 60 and day 90 | — |
Countries
India
Contacts
Public ContactDr Vaishnavi Patil
Life Synergy
Outcome results
None listed