A Randomized Double Blind Controlled Trial to Investigate the Effects of Vitamin D fortified milk on calcium-vitamin D-parathyroid hormone axis in school children, aged 11-14 years

DSM Nutritional Products India Pvt Ltd0 个研究点目标入组 780 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Subjects will be excluded from the study if they
•Have past or current history of renal stones
•Are taking or had taken vitamin D supplementation in last six months in doses exceeding 600 IU/day
•Have any systemic disease (cardiac, hepatic, endocrine or renal) or taking any kind of treatment
•more than one month in last six months.
•Are diagnosed malabsorption (celiac disease, Crohnâ??s dis, ulcerative colitis) or history suggestive
•of malabsorption especially history of milk allergy.
•Are using medications known to interact with vitamin D metabolism (steroids, thiazide diuretics,
•phenytoin, phenobarbitone, and antitubercular drugs)
•Have known hypersensitivity to vitamin D preparation
•Have participated in any other investigational drug study in previous three months
•Have features suggestive of osteomalacia or severe vitamin D deficiency
•Are using Ultra-Violet (UV) radiations as a part of medical therapy
•Are diagnosed with albinism or have other condition associated with decreased skin pigmentation
•Have any medical condition that in the judgment of the investigator would jeopardize the
•subjectâ??s safety or evaluation of study drug for efficacy or safety
•Have serum calcium more than 1 mg/dL above the upper limit of normal for age
•Have hypercalciuria as per definition
•Have serum 25-hydroxy vitamin D level more than 100 ng/mL

发起方

DSM Nutritional Products India Pvt Ltd