A double-blind, placebo-controlled clinical trial to evaluate the effect Vitamin B12 supplementation in adults with marginal Vitamin B12 Deficiency
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Changes in vitamin B12 levels
研究概览
简要总结
Vitamin B12 supplementation in adults with marginal deficiency can improve various physiological and neurological outcomes. Marginal B12 deficiency, often caused by dietary inadequacies or malabsorption, may lead to symptoms like fatigue, mild cognitive impairment, and mood disturbances. Studies suggest that supplementation (via oral or intramuscular routes) effectively increases serum B12 levels and improves related biomarkers, such as homocysteine and methylmalonic acid, which are associated with cardiovascular and neurological health. Additionally, supplementation may alleviate symptoms like low energy and memory issues, though the extent of benefit varies. Early intervention is key to preventing progression to more severe deficiencies and irreversible complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Men and women aged 18 years or older who follow a vegetarian, vegan diet
- •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
- •Sign the informed consent.
排除标准
- •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
- •Medical history of abdominal surgery that may influence the absorption of vitamin B12 (such as bariatric surgery)
- •Being on hemodialysis treatment
- •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
- •Having consumed or consuming vitamin B12 or folate supplements for more than 2 months before inclusion in the study
- •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
- •Participants with known systemic and metabolic diseases in the investigators discretion not proving fit for trial
- •Known hypersensitivity to investigational products
- •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
- •Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
- •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
- •Donated blood within two months before study entry, and must not donate blood during the study duration
- •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
- •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.
结局指标
主要结局
1. Changes in vitamin B12 levels
时间窗: 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
2. Changes in State-Trait Anxiety Inventory score
时间窗: 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
3. Changes in Fatigue severity scale score
时间窗: 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
4. Assessment of energy audit diary
时间窗: 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
5. Changes in Health Organization Quality of Life (WHOQOL BREF) questionnaire score
时间窗: 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
次要结局
- 1. Adverse events profile(2. Compliance and tolerability of the investigational product)
研究者
Dr Ramshyam Agarwal
Lokmanya Medical Research Centre and Hospital