Pilot Study for the Evaluation of the Effectiveness of Natural Versus Synthetic Vitamin B Complexes in Humans.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Serum Thiamine
研究概览
简要总结
In a cross-over study the investigators evaluate the effects of natural (Panmol-B-Complex) (Pan [Greek] = all; moles [Latin] = molecules/particles - brand name) versus synthetic vitamin B complexes to identify the bioavailability of distinct vitamins as well as long-term effects. The primary hypothesis for this study: "Natural Vitamin B-complexes are as effective as synthetic Vitamin B-complexes or better." For this reason 30 subjects (18 to 65y; BMI >19 to <29) were recruited for this study. The study population was divided into 2 groups of each 15 subjects in a cross-over trial. Vitamin supplementation consisted of Thiamine (2.93 mg), Riboflavin (3.98 mg), Niacin (29.85 mg), Pantothenic acid (10.95 mg), Pyridoxine (3.38 mg), Biotin (0.108 mg), Folic acid (0.69 mg) and Cobalamin (8.85 µg) per day in both groups. Blood samples are taken at baseline - 1.5h after vitamin supplementation - 4h - 7h - 6 weeks - wash out phase I (2 weeks); start cross-over: baseline - 1.5h after vitamin supplementation - 4h - 7h - 6 weeks - washout phase II (6 weeks). In case of main target criteria Thiamin, Riboflavin, Pyridoxine, Folic acid and Cobalamin were measured in serum as well as total peroxides (µmol/L), peroxidase-activity (U/L), total antioxidant status (mmol/L) and polyphenols (mmol/L).
详细描述
Design:
Monocentric double-blind experiment
Scientific background:
Vitamin B-complex is water-soluble and essential for humans. Vitamin B deficiency is associated with neurologic diseases, heart insufficiency, diminished hormone production and maldigestion. Due to the fact that literature search did not reveal distinct information about natural versus synthetic Vitamin B-complexes this study was initiated to investigate bioavailability and long-term effects of natural Vitamin B-complexes in comparison to synthetic Vitamin B-complexes.
Vitamin B complex was filled in hydroxypropylmethylcellulose capsules (size 0, ivory-coloured). Daily dose = 3 capsules in the morning with 250ml water.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Masking was organized and supervised by the randomization person in charge. Group assignment was 1:1 (control vs. verum group) with identical packages for both Vitamin supplements with 126 capsules for each subject per phase. Randomization was done with sealed envelopes.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female
排除标准
- •Cholesterol >240mg/dl
- •Study inclusion in the past 2 months
- •Pregnancy and lactation period
- •Clinical diagnosis of chronic infections
- •Ingestion of trace elements, vitamin- and fatty acid supplements in the past 3 months
- •Clinical diagnosis of cardiovascular disease
- •Clinical diagnosis of cancer
- •Clinical diagnosis of psychotic diseases
- •Insulin dependent diabetes
- •Clinical diagnosis of autoimmune diseases
- •Maldigestion/Malabsorption
- •Veganes cuisine
- •> 1 Beer/day
结局指标
主要结局
Serum Thiamine
时间窗: 20 weeks
Serum Thiamine in microgram per liter Minimum: 36 Maximum: 98
Serum Riboflavin
时间窗: 20 weeks
Serum Riboflavin in microgram per liter Minimum: 190 Maximum: 341
Serum Folic Acid
时间窗: 20 weeks
Serum Folic acid in nanogram per liter Minimum: 2.20 Maximum: 58.10
Serum Cobalamin
时间窗: 20 weeks
Serum Cobalamin in picogram per liter Minimum: 159 Maximum: 1230
Serum Pyridoxine
时间窗: 20 weeks
Serum Pyridoxine in microgram per liter Minimum: 3.8 Maximum: 161.8
次要结局
- Serum Total Peroxides(20 weeks)
- Serum Total Antioxidant Capacity(20 weeks)
- Total Homocysteine(20 weeks)
- Serum Polyphenols(20 weeks)
- Serum Endogenous Peroxidase-activity(20 weeks)
研究者
Priv.-Doz. Mag. Dr. Willibald Wonisch
Principal Investigator
Medical University of Graz