Vitamin D's Effect on Physical Performance in the Elderly

Completed · Not applicable · Has a placebo group

Conditions studied: Family Member

In brief

The purpose of this study is to compare vitamin D deficient and vitamin D sufficient elderly individuals and examine the effect of a vitamin D dietary supplement on serum vitamin D level, bone formation, resorption, and mineral density, flexibility, balance, general inflammation,and quality of life. Enhancing nutritional status is necessary to prevent the continued proliferation of chronic diseases, e.g., bone disease and other chronic disorders thought to now be related to low levels of vitamin D, which are some of the leading disablers and killers of Americans. Americans also have difficulties with compliance to prescription medications due to their toxicity and side effects. This study aims to learn more about how a vitamin D nutritional supplement may improve nutritional status and enable the body to normalize system functioning,which may improve the quality of life for people with vitamin D deficiency. The results of this research will be used to determine if vitamin D is beneficial for overall health among elderly individuals.

Key facts

Study ID

NCT02066441

Run by

University of Miami

People needed

101

Starts

2014-02-01

Expected to finish

2015-01-01

Last updated by the study team

2015-05-19

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and women ages 55 years and over
• English or Spanish speaking
• Interest in participating in a novel nutritional supplement program
• Willingness to follow recommendations, including going off of all vitamin-D and calcium containing supplements, multivitamins, or OTC medications (e.g., Tums) 2 weeks before starting the study and during the intervention
• Scoring 0-2 errors on the Short Portable Mental Status Questionnaire

You may not qualify if…

• Less than 55 years of age
• Currently enrolled in another research trial for vitamin D dietary supplements or other bone disease treatments
• Unable to consent to the study
• Living in a skilled or intermediate care level nursing facility
• Women who are pregnant, during their period, or less than 2 days before or after their period at the time of the assessment
• Psychiatric diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, major depression with psychotic features, delirium, and alcohol or substance abuse/dependence
• Bleeding disorders
• Aphasia or sensory, motor, and/or visual disturbances that could interfere with assessments, including inability to walk 10 feet without a walking aid
• Gastrointestinal disorders that could lead to uncertain resorption of the study supplements
• Major conditions such as neurologic, cardiovascular, pulmonary, renal, endocrine, thyroid, hepatic, autoimmune, or bone/joint that could interfere with vitamin D metabolism, psychometric tests, or body composition assessment (especially renal and heart failure)
• Erratic, accelerated, or mechanically-controlled irregular heart rhythms, atrial fibrillation/flutter, or atrioventricular block or implanted electronic device
• Any condition restricting blood flow, such as severe systemic vascular resistance
• Acute fever, diarrhea, or edema at the time of the assessment
• Dermatological lesions or excessive hair that would be in contact with the placement of the electrodes for the ESC assessment
• Hematologic or oncologic disorders treated with chemotherapy in the previous two years
• Dysfunctional levels of hemoglobins like carboxyhemoglobin or methemoglobin
• Active chemotherapy or radiation treatment for cancer
• Recent infusion of dyes into the bloodstream such as methylene blue, indocyanine green, indigo carmine, or fluorescein
• Diagnosis of a terminal illness
• Persons may not be in the second part of the study while participating in another trial for drugs, supplements, or treatment that affects serum vitamin D level
• Persons may not be in the second part of the study if they are unwilling to go off all vitamin D and calcium containing supplements, multivitamins, and over the counter medications 2 weeks prior to starting the study and for the duration of the second part of the study
• Persons may not be in this study if they are unwilling to have their blood drawn
• Persons may not be in the second part of the study if they are taking steroids, HCTZ, or any other drug known to interfere with vitamin D metabolism or taking diuretics or any other drug that interferes with hydration status
• Persons may not be in this study if they are unwilling to refrain from alcohol, caffeine, and stimulants (amphetamines) 12 hours before the examination
• Persons may not be in this study if they are unwilling to stop physical activity or sauna use 8 hours before the examination

Where it is running

• University of Miami Clinical Research Building — Miami, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.