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This study evaluated vitamin D and calcium supplements (Euro D and Ci-CalD) and their effect on bone-mineral and fat-energy metabolism in older adults with vitamin D deficiency (hypovitaminosis D). It enrolled people aged 65 and over with a higher body mass index. It was carried out in Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Elderly subjects (\> or equal to 65 years old)without any disease mentioned in the exclusion criteria. * BMI ≥ 25Kg/meters squared Exclusion Criteria: * Exclusion criteria include: diabetes, subjects with impaired glucose tolerance on medication, presence of a chronic disease or major organ failure such as severe heart failure, kidney or liver failure, conditions or intake of medications known to affect bone metabolism, rickets or osteomalacia, history of kidney stones, a baseline vitamin D level of less than 10 ng/ml and history of fragility fractures or an overall fracture risk based on FRAX of \>10% . * Subjects with impaired glucose tolerance on no medications will not be excluded. * The classification of individuals as diabetics or having impaired glucose tolerance will be based on the American Diabetes Association criteria for diagnosis.