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NCT01145703 · ClinicalTrials.gov registry record · NA

Vitamin D Supplementation and Metabolism in Vitamin D Deficient Elderly

A NA study, sponsored by Baltimore VA Medical Center.

Terminated
Registry status
NA
Development phase
39
Enrollment target

NCT01145703 is a NA study that was terminated before completion, run by Baltimore VA Medical Center. The registered enrollment target is 39 participants.

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The verdict

NCT01145703, a NA study, was terminated before completion, sponsored by Baltimore VA Medical Center.

TERMINATED
Registry status
NA
Development phase
39 participants
Enrollment target

Study Summary

The purpose of this study is to examine the effects of Vitamin D supplementation on the reasons (mechanisms) underlying the development of type 2 diabetes, metabolic syndrome (high blood pressure, cholesterol, diabetes, body weight/obesity), muscle weakness and wasting (sarcopenia), and impaired physical function (poor balance and walking) associated with vitamin D deficiency and osteopenia/osteoporosis (bone loss). The investigators obtain vitamin D through our diet and sunlight, and its conversion to active vitamins in the liver and kidneys promotes the intestinal absorption of calcium and regulation of bone growth. Therefore, vitamin D deficiency has been known for years to lead to weakened bones (osteopenia and osteoporosis). However, more recently, studies show vitamin D deficiency is associated with a number of other diseases, including type 2 diabetes, muscle weakness, frailty, and the metabolic syndrome. It has also been associated with cognitive impairment. Diabetes affects multiple organ systems including the heart, kidneys, musculoskeletal and nervous system. The possibility that vitamin D deficiency is linked to the development of type 2 diabetes, metabolic syndrome, muscle weakness and wasting (sarcopenia) and osteopenia/osteoporosis, and that vitamin D supplementation decreases the risk for these diseases, provides a relatively easy/accessible and inexpensive model of preventive therapy to decrease the incidence of these diseases. In addition, it is likely that genetic (inherited) factors play a role, but the relationship of these genes to these metabolic abnormalities have not been elucidated. Understanding the role of Vitamin D in health will allow us to translate these findings into therapy.

Interventions

  • DIETARY_SUPPLEMENT RDA Vitamin D3 only
  • DIETARY_SUPPLEMENT Vitamin D2/3 Repletion only
  • OTHER Vitamin D2/3 Repletion + AEX
  • OTHER Vitamin D2/3 Repletion + RT

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2010-05
Est. Completion 2013-02
Phase NA

Sponsor

Baltimore VA Medical Center

12 total trials

What the Registry Record Tells You About NCT01145703

The ClinicalTrials.gov registry entry for NCT01145703 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baltimore VA Medical Center, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which RDA Vitamin D3 only is the first listed.

NCT01145703 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01145703 about?

NCT01145703 is a clinical study titled "Vitamin D Supplementation and Metabolism in Vitamin D Deficient Elderly". The purpose of this study is to examine the effects of Vitamin D supplementation on the reasons (mechanisms) underlying the development of type 2 diabetes, metabolic syndrome (high blood pressure, cholesterol, diabetes, body weight/obesity), muscle weakness and wasting (sarcopenia), and impaired phy...

What is the current status of trial NCT01145703?

This trial is currently terminated. It is a NA study. The enrollment target is 39 participants. The study started on 2010-05. Estimated completion is 2013-02.

What interventions are being tested in trial NCT01145703?

The interventions under investigation include: RDA Vitamin D3 only (DIETARY_SUPPLEMENT), Vitamin D2/3 Repletion only (DIETARY_SUPPLEMENT), Vitamin D2/3 Repletion + AEX (OTHER), Vitamin D2/3 Repletion + RT (OTHER).

Who is sponsoring clinical trial NCT01145703?

This trial is sponsored by Baltimore VA Medical Center, which has 12 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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