OsteoporosisPhase 4NCT00581828
Does Treatment of Hypovitaminosis D Increase Calcium Absorption?
A Phase 4 study testing Vitamin D in people with Osteoporosis and Osteopenia, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 66 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteopenia, Vitamin D Deficiency
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Dec 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 66 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women at least five years past onset of menopause, defined as date of last menses (ages reported above are the range in ages of the participants recruited to the study)
- serum 25(OH)D 16-24 ng/ml by reverse phase HPLC
- calcium intake < or = 1,100 mg daily
Who cannot join
- Intake of >1,100 mg of calcium per day through the combination of diet and supplements
- Hypercalcemia (baseline serum calcium above the normal reference range)
- Nephrolithiasis, documented in the medical record or by patient report
- Inflammatory bowel disease, malabsorption, chronic diarrhea, or use of antibiotics within the past month
- Creatinine >2.0 mg/dL
- Hypercalciuria (baseline urine calcium: creatinine ratio >0.25)
Show all 10Show fewer
- Current use of medications known to interfere with vitamin D and/or calcium metabolism, including oral steroids or anticonvulsants
- Ongoing or recent (past six months) use of bisphosphonates, estrogen compounds, calcitonin or teriparatide, as these compounds may independently affect retention of calcium within bone
- Diagnosis of, or evidence for, osteomalacia, manifest by serum 25(OH)D < 16 ng/ml or the presence of at least two of the following blood tests: low calcium, low phosphorus, or elevated alkaline phosphatase (23).
- Prior adult clinical fragility fracture or baseline T-score below -3.0 at the lumbar spine or femur
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
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.
Read the detailed description
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.
- Conditions
- Osteoporosis, Osteopenia, Vitamin D Deficiency, Hypoparathyroidism, Hypercalciuria, Hypercalcemia
- Being tested
- Vitamin D
- Keywords
- Calcium Absorption, Intestinal Absorption of Calcium, Fractional Calcium Absorption, Stable Calcium Isotopes, Hypovitaminosis D, Vitamin D, Bone Mineral Density, Physical Function
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Vitamin D Deficiency, Hypoparathyroidism, Hypercalciuria, Hypercalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called Vitamin D2, Ergocalciferol
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)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months). Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intestinal Calcium Absorption From Baseline to One Month
percent and true fractional calcium absorption
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startJan 2005
- Primary completionJul 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen E Hansen, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581828
- Sponsor's protocol ID
- 2005-0159
- Other IDs
- 05-1235-02
- Status last verified
- Sep 2012
- First submitted
- 19 Dec 2007
- Last updated
- 24 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hansen KE, Jones AN, Lindstrom MJ, Davis LA, Engelke JA, Shafer MM. Vitamin D insufficiency: disease or no disease? J Bone Miner Res. 2008 Jul;23(7):1052-60. doi: 10.1359/jbmr.080230.
PubMed 18302509
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Treatment of Hypovitaminosis D Increase Calcium Absorption?
- ClinicalTrials.gov ID
- NCT00581828
- Acronym / sponsor ID
- 2005-0159
- Conditions
- Osteoporosis, Osteopenia, Vitamin D Deficiency, Hypoparathyroidism, Hypercalciuria, Hypercalcemia
- Keywords
- Calcium Absorption, Intestinal Absorption of Calcium, Fractional Calcium Absorption, Stable Calcium Isotopes, Hypovitaminosis D, Vitamin D, Bone Mineral Density, Physical Function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 28 Dec 2007 (estimated)
- Results
- Posted 14 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Vitamin DSubjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months). |
Who may qualify
- Ages
- 50 to 66 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women at least five years past onset of menopause, defined as date of last menses (ages reported above are the range in ages of the participants recruited to the study)
- serum 25(OH)D 16-24 ng/ml by reverse phase HPLC
- calcium intake < or = 1,100 mg daily
Key exclusion criteria (10 listed)
- Intake of >1,100 mg of calcium per day through the combination of diet and supplements
- Hypercalcemia (baseline serum calcium above the normal reference range)
- Nephrolithiasis, documented in the medical record or by patient report
- Inflammatory bowel disease, malabsorption, chronic diarrhea, or use of antibiotics within the past month
- Creatinine >2.0 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: Vitamin D2, Ergocalciferol50,000 IU po qd for 15 days and 50,000 IU po twice month for 10 months (until final study visit at one year) | Drug | 1 |
Primary outcome
Change in Intestinal Calcium Absorption From Baseline to One Month
Time frame: 1 month
percent and true fractional calcium absorption
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18302509Hansen KE, Jones AN, Lindstrom MJ, Davis LA, Engelke JA, Shafer MM. Vitamin D insufficiency: disease or no disease? J Bone Miner Res. 2008 Jul;23(7):1052-60. doi: 10.1359/jbmr.080230.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen E Hansen, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D in people with Osteoporosis and Osteopenia, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intestinal Calcium Absorption From Baseline to One Month (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00581828, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.