A Phase 4 interventional study of Vitamin D in Osteoporosis, Osteopenia and Vitamin D Deficiency, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to female participants aged 50 Years to 66 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-24.
Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Treatment
The purpose is to perform a one-year study designed to assess whether treatment of hypovitaminosis D increases intestinal absorption of calcium, subsequent retention of calcium within bone, decreases bone turnover, and favorably impacts upon skeletal muscle mass, functional status, measures of physical function and quality of life. I hypothesize that treatment of hypovitaminosis D results in improved intestinal calcium absorption, greater retention of calcium within the bone reservoir and improved physical function, quality of life and muscle mass.
Postmenopausal women with vitamin D insufficiency will participate in this one-year study. We will study the change in intestinal calcium absorption from baseline (vitamin D insufficiency) to follow up (vitamin D repletion and whether increased absorption results in subsequent increased retention of calcium within bone over the one-year interval as measured by bone densitometry. We will also study the effect of vitamin D repletion upon whole body muscle mass, quality of life and physical function.
A review of medical records and a screening visit will determine eligibility. Eligible and consenting subjects will present to the GCRC in the early morning and following baseline labs, will consume breakfast with a glass of orange juice enriched with a stable calcium isotope, and will receive 3 mg of another stable calcium isotope by intravenous injection. Over the next eight hours, blood will be taken a total of 9 more times and over the first 24 hours, all urine and stool will be collected for measurement of its calcium content.
Subsequently for the next five days, women will collect three urine specimens daily. Women will then receive vitamin D to treat vitamin D deficiency. Once vitamin D repletion is accomplished, all women will repeat their 24-hour visit and subsequent five-day urine collections. Women will maintain vitamin D repletion by taking a twice monthly tablet (50,000 IU) of vitamin D2. To confirm vitamin D repletion and safety over the full one year study, additional study visits will occur at 3, 6 and 12 months.
A bone density test at screening and twelve months will allow us to assess the effect of vitamin D repletion on whole body bone mass and skeletal mass. At each GCRC stay, 3, 6 and 12 months, women will complete questionnaires regarding quality of life and functional status and will perform the Timed Up and Go Test. Because we wish to maintain and confirm constant calcium intake throughout the one- year study, women will complete a calcium questionnaire at baseline, 3, 6 and 12 months.
With each subject's consent, we will collect one tube of blood and isolate its DNA. When sufficient knowledge is available regarding the pathophysiologic mechanisms whereby genetic polymorphisms impact calcium homeostasis, we will test for such DNA polymorphisms and relate genetic information with other data collected on calcium homeostasis.
1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
This study's enrollment of 19 is below the median of 88 across 1,084 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
Drug: Vitamin D
50,000 IU po qd for 15 days and 50,000 IU po twice month for 10 months (until final study visit at one year)
Also known as: Vitamin D2, Ergocalciferol
Change in Intestinal Calcium Absorption From Baseline to One Month
percent and true fractional calcium absorption
Time frame: 1 month
| Milestone | Vitamin D |
|---|---|
| Started | 19 |
| Completed | 18 |
| Not completed | 1 |
| Withdrew: Protocol violation | 1 |
percent and true fractional calcium absorption
| percent calcium absorption | Vitamin D |
|---|---|
| Change in Intestinal Calcium Absorption From Baseline to One Month | 3 ± 1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vitamin D | — | 0/19 (0%) | 0/19 (0%) |
| Age, Categorical(Participants) | Vitamin D |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 18 |
| >=65 years | 1 |
| Age, Continuous(years) | Vitamin D |
|---|---|
| Mean | 58 ± 8 |
| Sex: Female, Male(Participants) | Vitamin D |
|---|---|
| Female | 19 |
| Male | 0 |
| Region of Enrollment(participants) | Vitamin D |
|---|---|
| United States | 19 |
The record gives a start of Jan 2005, a primary completion of Jul 2008 and a completion of Dec 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2012, 4 years 2 months after primary completion.
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This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vitamin D
University of Wisconsin, Madison →