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| ID | Type | Description | Link |
|---|---|---|---|
| 00085737-8 | Other Identifier | University of Florida |
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The role of vitamin D deficiency on increased risk for falls and physical dysfunction is unclear. It is also unclear if taking vitamin D improves physical function and reduces fall risk in older adults. The purpose of this research study is to explore the effects of taking the recommended dose of vitamin D (800 IUs/day) for six months on fall risk and physical functional outcomes in older adults with low vitamin D levels. The investigators hypothesize that the participants will experience fewer falls and function better physically after taking vitamin D for six months.
The role of vitamin D deficiency on increased risk for falls and physical dysfunction is unclear. It is also unclear if taking vitamin D improves physical function and reduces fall risk in older adults. This study will look at the potential effects of taking vitamin D regularly on falls and physical function in older adults. A total of 50 individuals with low vitamin D levels (i.e., serum 25-hydroxy Vitamin D range 10 ng/mL to 30 ng/mL) and a recent fall history will be enrolled into a six-month study. During the 6 months in this study, participants will receive capsules containing 800 IU vitamin D, in non-childproof bottles, for two 3-month periods. Participants will be asked to consume one capsule per day for the duration of this six-month study, as well as attend four study visits: Screening Visit, Baseline Visit, 3-Month Visit (in approximately 3 months from the baseline visit), and 6-Month Visit (in approximately 6 months from the baseline visit). During the screening visit, participants will fill out questionnaires, complete the mini-mental status exam, have their blood pressure and pulse taken, and a small sample of blood will be drawn from their vein. During the baseline visit, participants will fill out questionnaires, have their blood pressure, pulse, height, weight, and waist circumference taken, and perform several measures of physical function. Finally, a mouth swab will be performed and a staff member will collect a stool sample that you brought to the study visit. During the 3-Month Visit, participants will complete a questionnaire and have their blood pressure and pulse taken. During the 6-Month Visit, participants will repeat the questionnaires and measures that they performed during the Baseline Visit. The investigators hypothesize that the participants will experience fewer falls and function better physically after taking vitamin D for six months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental | Participants will take the Institute of Medicine's recommended daily dose of vitamin D (800 IU/day) for six months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | Participants will take the Institute of Medicine's recommended daily dose of vitamin D (800 IU/day) for six months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Falls | Assess the change in number of falls participants have after taking vitamin D for six months. | Change in 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Six Minute Walk Test | Assess the change in gait speed on the Six Minute Walk Test after taking vitamin D for six months. | Change in 6 Months |
| Short Physical Performance Battery (SPPB) | Assess the change in functional performance on the SPPB after taking vitamin D for six months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen D Anton, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute on Aging; University of Florida | Gainesville | Florida | 32611 | United States |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Change in 6 Months |
| Grip Strength | Assess the change in grip strength after taking vitamin D for six months. | Change in 6 Months |
| Weight | Assess the change in weight after taking vitamin D for six months. | Change in 6 Months |
| Waist Circumference | Assess the change in waist circumference after taking vitamin D for six months. | Change in 6 Months |
| Perceived Level of Functioning as Measured by the Activity Measure for Post-Acute Care (AM-PAC) | Assess the change in perceived level of functioning as measured by the Activity Measure for Post-Acute Care (AM-PAC) after taking vitamin D for six months. | Change in 6 Months |
| Medical Outcomes Study Short-Form Health Survey (SF-36) | Assess the change in health-related quality of life after taking vitamin D for six months. | Change in 6 Months |
| Microbiome in the Human Colon | Assess the change in microbiome in the human colon after taking vitamin D for six months. Analyses of changes in bacterial diversity will be accomplished by deep sequencing of the ribosomal RNA, a highly conserved molecule that is used to classify bacteria. | Change in 6 Months |
| Microbiome in the Human Mouth | Assess the change in microbiome in the human mouth after taking vitamin D for six months. Analyses of changes in bacterial diversity will be accomplished by deep sequencing of the ribosomal RNA, a highly conserved molecule that is used to classify bacteria. | Change in 6 Months |
| D009750 |
| Nutritional and Metabolic Diseases |