None listed
Conditions
Brief summary
Formulating a supplement with the appropriate ratios of vitamin D and vitamin B12 ensures that individuals get a balanced intake of these nutrients. This can be important for people who have specific health concerns or conditions that may benefit from a particular combination.Purchasing a single supplement containing both vitamin D and vitamin B12 may be more cost-effective than buying two separate supplements. The aim of this study is to assess the efficacy of a novel dispersible tablet combining 1000mg of B12 and 2500IU of vitamin D in restoring normal levels of these vitamins.
Interventions
Randomized, three- arms controlled trial. Two interventional arms and one control arm. Patients with vitamin D and B12 insufficiency will be treated with cholecalciferol-containing supplements and vitamin b12 supplements, or a novel supplement containing both vitamin D and b12.
Participants will be randomized to treatment arms ( Arm1 and Arm2) or control group (Arm3) .
Arm 1: Novel supplement containing both vitamin D (2500IU) and b12 (1000mg), taken once daily for 90 days via oral dispersible
Randomized, three- arms controlled trial. Two interventional arms and one control arm. Patients with vitamin D and B12 insufficiency will be treated with cholecalciferol-containing supplements and vitamin b12 supplements, or a novel supplement containing both vitamin D and b12. Participants will be randomized to treatment arms ( Arm1 and Arm2) or control group (Arm3) . Arm 1: Novel supplement containing both vitamin D (2500IU) and b12 (1000mg), taken once daily for 90 days via oral dispersible tablets. Arm 2: Two supplements: One dispersible oral tablet containing 1000mg of B12, daily for 90 days and one oral tablet containing 2000IU of vitamin D, daily for 90 days, after lunch. Arm 3: No treatment, active surveillance Compliance will be monitored via drug tablet return in the end of the study.
Sponsors
Nicholaos Angelopoulos,MD,Phd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients with serum vitamin d levels lower than 25 ng/dl and b12 levels lower than 250 ng/L
Exclusion criteria
1.individuals who have been taking vitamin D supplements regularly or at high doses prior to the study. 2.Medications affecting vitamin D metabolism: Exclude individuals who are taking medications known to interfere with vitamin D metabolism or absorption, such as antiepileptic drugs (phenytoin, phenobarbital), glucocorticoids (prednisone), or certain weight-loss medications (orlistat). 3.Chronic kidney disease 4.Other metabolic disorders: individuals with specific metabolic disorders that could impact vitamin D metabolism or lead to altered vitamin D levels, such as primary hyperparathyroidism, hyperthyroidism, or malabsorption syndromes (e.g., celiac disease, Crohn's disease). 5.Conditions that significantly affect bone health, such as osteoporosis, osteomalacia, or Paget's disease. 6.Pregnancy and breastfeeding 7.Severe illnesses or comorbidities: terminal cancer, uncontrolled diabetes, or autoimmune disorders. 8. Drugs that affect vitamin b12 metabolism: Drugs • Alcohol • Nitrous oxide • Proton pump inhibitors • H2 receptor antagonists • Metformin • Colchicine • Slow K (potassium chloride) preparations • Cholestyramine 9. History of bariatric surgery and/or stomach operation
Outcome results
None listed