CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 257 enrolled
Drug / intervention
Euro D and Ci-CalD +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01315366
NCT01315366Phase 3Completed
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Phase III Study on the Effect of Vitamin D Supplementation on Indices of Mineral and Musculoskeletal Metabolism and on Parameters of Glucose and Fuel Metabolism in Elderly Subjects

American University of Beirut Medical Center·interventional·Posted Mar 15, 2011·Updated Nov 20, 2015

In Brief

A Phase 3 clinical trial evaluating Euro D and Ci-CalD and Euro D, Ci-CalD for Hypovitaminosis D and 3 related conditions. Completed, enrolled 257 participants across 1 site.

Detailed Summary

The optimal dose of vitamin D needed to optimize beneficial effects on musculoskeletal outcomes remains to be defined. Equally unclear is the impact of vitamin D on fuel metabolism and insulin sensitivity in human subjects. Thus, the overall objective of this proposal is to test the hypothesis that in ambulatory overweight elderly individuals, vitamin D administration at doses higher than currently recommended will: 1. Have a salutary effect on parameters of glucose and fuel metabolism. It will thus decrease indices of insulin resistance, improve lipid profile, and decrease markers of cardiovascular disease including adipokines, inflammatory cytokines, and markers of cell adhesion. 2. Have a superior effect on indices of mineral and musculoskeletal metabolism, including bone remodeling markers, lean mass, and bone mineral density. We will investigate whether this effect is modulated by entry status of vitaminD and PTH as detailed below

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypovitaminosis D, Insulin Resistance, Obesity, Osteoporosis
CountriesLebanon
CollaboratorsHotel Dieu de France Hospital, Rafic Hariri University Hospital

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 15, 2011
Enrollment StartJan 1, 2011
Primary CompletionAug 1, 2014
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 15.3 years ago

Interventions

Euro D and Ci-CalDdietary

Ci-Cal D (1000mg/day) and vitamin D (500IU/day) daily, plus a supplement of vitamin D3 (20,000 IU/wk) for one year.

Euro D, Ci-CalDdietary

Ci-Cal D(1000mg/day) and vitamin D (500IU/day) Ci-CalD daily, plus a weekly placebo Euro D supplement for one year.