DRKS00009770已完成未知
Effect of multimicronutrient supplementation on vitamin D status in women of childbearing age - BTS917/15
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 201
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Female
入选标准
- •1)Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- •2)Healthy volunteers: Subject is in good physical and mental health as established by medical history, physical examination, vital signs, results of biochemistry and haematology
- •3)Women of childbearing age
- •4)Age = 18 and = 45 years
- •5)BMI: 17-30 kg/m2
- •6)No travel into southern countries in the past 30 days
- •7)No plans to travel into southern countries during the study
- •8)Able and willing to follow the study protocol procedures
排除标准
- •1)For this study clinically relevant abnormal, vital signs or physical findings at screening and abnormal laboratory finding at visit 1
- •2)Taking any medication interfering with vitamin D metabolism, e.g. cardiac glycosides, barbitu-rates, anti-tuberculosis drugs (rifampicin, isoniazid), cholestyramine, glucocorticoids (except inhalative), benzothiadiazine derivates, anti-convulsants, PTH or PTH derivates in the past 6 months
- •3)Vitamin D prescription
- •4)Intake of the antibiotics Pyrimethamin or Trimethoprim two weeks prior to visit 1 as both anti-biotics interfere with the folate metabolism.
- •5)Taking other dietary supplements/medication with folate and/or vitamin D in the past 2 months.
- •6)Concomitant use of cod liver oil or intake during the past 2 months
- •7)Because of thyroid disorder intake of iodine contraindicated
- •8)Sarcoidosis or any other granuloma-forming inflammatory disease
- •9)Osteoporosis, Osteomalacia
- •10)History of diabetes, stroke, CVD, cancer
- •11)Fat malabsorption (Crohn’s or celiac disease, cystic fibrosis)
- •12)Gastrointestinal diseases/conditions (colitis ulcerosa, Crohn’s IBS, IBD, peptic ulcers) hinder-ing Vit. D absorption
- •13)Liver or renal disease (including alcoholism)
- •14)Pancreatic insufficiency (disturbed fat metabolism)
- •15)Ca kidney stones or history of hypercalcaemia and hypercalciuria
- •16)Psychological disorders
- •17)Calcium metabolism disorders
- •18)Hypo-& and Hyperparathyroidism
- •19)Participants anticipating a change in their lifestyle or physical activity levels during the study.
- •20)Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study.
- •21)Known hypersensitivity to the study preparation or to single ingredients (e.g. allergy to crus-taceans or fish)
- •22)Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject.
- •23)Known HIV-infection
- •24)Known acute or chronic hepatitis B and C infection
- •25)Blood donation within 4 weeks prior to visit 1 or during the study.
- •26)Subject involved in any clinical or food study 4 weeks prior to visit 1
研究者
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