Vitamin D InsufficiencyNCT00690417
Vitamin D Inadequacy in Rural Populations, Evaluation of Correction by Food Supplementation
A study testing Cholecalciferol (vitamin D3) in people with Vitamin D Insufficiency and Vitamin D Deficiency, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of the research is to describe vitamin D levels and bone status in a rural Wisconsin population. It is probable that individuals of varying age and ethnicity require different amounts of D to achieve optimal status. These likely scenarios will be explored in various populations. Read more about this study
- Who is it for?
- Ages 55 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Insufficiency, Vitamin D Deficiency
- What is being tested?
- Cholecalciferol (vitamin D3)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, community-dwelling ambulatory women.
- Able and willing to sign informed consent.
- Ages: 20-30, 55-65 or >75
- Baseline serum 25OHD concentration > 10 ng/ml and < 60 ng/ml
- Not pregnant
- Willing to avoid use of cod-liver oil and non-study vitamin D supplementation; standard multiple vitamins containing ≤ 400 IU used no more than once daily will be allowed.
- Willing to utilize sunscreen of SPF-15 or higher when sun exposure for more than 15 minutes is expected.
Who cannot join
- Current hypercalcemia (serum calcium > 10.5 mg/dl) or untreated primary hyperparathyroidism.
- History of nephrolithiasis
- Baseline 24-hour urine calcium > 250 mg
- Known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis, Paget's disease.
- History of any form of cancer within the past five years with the exception of adequately treated squamous cell or basal cell skin carcinoma.
- Renal failure; defined as a calculated creatinine clearance (using the Cockroft-Gault approach) of ≤ 25 ml/minute.
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- Severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which might limit the ability to complete this study.
- Treatment with any drug known to interfere with vitamin D metabolism, e.g., phenytoin, phenobarbital.
- Known malabsorption syndromes, e.g., celiac disease, active inflammatory bowel disease, etc.
- Known allergy to chocolate.
- Use of medications known to alter bone turnover including bisphosphonates, estrogen, selective estrogen receptor modulators, parathyroid hormone, testosterone or calcitonin.
- Treatment with high dose vitamin D (≥ 50,000 IU weekly) or any active metabolites of vitamin D, e.g., calcitriol, within six months of screening.
- Use of tanning beds or salons or unwillingness to utilize sunscreen during periods of sun exposure of 15 minutes or longer.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Osteoporosis Clinical and Research Program
Madison, Wisconsin, 53705
About this study
Official title: Vitamin D Inadequacy: Documentation in Rural Populations and Evaluation of Correction by Food Supplementation (Phase III; Manitowoc Prevalence Study)
The purpose of the research is to describe vitamin D levels and bone status in a rural Wisconsin population. It is probable that individuals of varying age and ethnicity require different amounts of D to achieve optimal status. These likely scenarios will be explored in various populations. We hypothesize that the increase in serum 25(OH)D resulting from daily D3 ingestion is less pronounced with advancing age and different in Native than Caucasian Americans. In addition, the women in the middle age group, between the ages of 55 and 65, will have ultrasound tests completed to assess the impact of the Vitamin D supplementation on cardiovascular health.
- Conditions
- Vitamin D Insufficiency, Vitamin D Deficiency
- Being tested
- Cholecalciferol (vitamin D3)
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecalciferol (vitamin D3)Dietary supplement
low calorie (~60 calories) cookie-like disc containing 2,500 IU of vitamin D3, taken by mouth daily for 4 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Dietary Supplement: Cholecalciferol (vitamin D3) |
| 2. 2500 IU vitamin D in a food preparation | Active comparator | Daily ingestion of 2500 IU vitamin D in a food preparation. Receives: Dietary Supplement: Cholecalciferol (vitamin D3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the primary outcome is the proportion of postmenopausal women with D inadequacy defined by current consensus as a serum 25(OH)D < 30 ng/ml.
Measured: 2.5 years
Secondary outcomes (2)
Prevalence of Vitamin D insufficiency in rural populations and ethnic differences in response to vitamin D supplementation
Measured: 2.5 year
The relationship between vitamin D supplementation and cardiovascular disease.
Measured: 2.5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startAug 2007
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D InsufficiencyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil Binkley, MD, Principal investigator, University of Wisconsin - Institute on Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690417
- Sponsor's protocol ID
- 2007-0211
- Status last verified
- Nov 2011
- First submitted
- 7 Jan 2008
- Last updated
- 24 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Gepner AD, Ramamurthy R, Krueger DC, Korcarz CE, Binkley N, Stein JH. A prospective randomized controlled trial of the effects of vitamin D supplementation on cardiovascular disease risk. PLoS One. 2012;7(5):e36617. doi: 10.1371/journal.pone.0036617. Epub 2012 May 7.
PubMed 22586483
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Inadequacy: Documentation in Rural Populations and Evaluation of Correction by Food Supplementation (Phase III; Manitowoc Prevalence Study)
- ClinicalTrials.gov ID
- NCT00690417
- Acronym / sponsor ID
- 2007-0211
- Conditions
- Vitamin D Insufficiency, Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 4 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the research is to describe vitamin D levels and bone status in a rural Wisconsin population. It is probable that individuals of varying age and ethnicity require different amounts of D to achieve optimal status. These likely scenarios will be explored in various populations. We hypothesize that the increase in serum 25(OH)D resulting from daily D3 ingestion is less pronounced with advancing age and different in Native than Caucasian Americans. In addition, the women in the middle age group, between the ages of 55 and 65, will have ultrasound tests completed to assess the impact of the Vitamin D supplementation on cardiovascular health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: Cholecalciferol (vitamin D3) |
| 2. 2500 IU vitamin D in a food preparation | Active comparator | Dietary Supplement: Cholecalciferol (vitamin D3)Daily ingestion of 2500 IU vitamin D in a food preparation. |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy, community-dwelling ambulatory women.
- Able and willing to sign informed consent.
- Ages: 20-30, 55-65 or >75
- Baseline serum 25OHD concentration > 10 ng/ml and < 60 ng/ml
- Not pregnant
Key exclusion criteria (13 listed)
- Current hypercalcemia (serum calcium > 10.5 mg/dl) or untreated primary hyperparathyroidism.
- History of nephrolithiasis
- Baseline 24-hour urine calcium > 250 mg
- Known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis, Paget's disease.
- History of any form of cancer within the past five years with the exception of adequately treated squamous cell or basal cell skin carcinoma.
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 |
|---|---|---|
| Cholecalciferol (vitamin D3)low calorie (~60 calories) cookie-like disc containing 2,500 IU of vitamin D3, taken by mouth daily for 4 months | Dietary supplement | 1, 2. 2500 IU vitamin D in a food preparation |
Primary outcome
the primary outcome is the proportion of postmenopausal women with D inadequacy defined by current consensus as a serum 25(OH)D < 30 ng/ml.
Time frame: 2.5 years
2 secondary outcomes
Prevalence of Vitamin D insufficiency in rural populations and ethnic differences in response to vitamin D supplementation
Time frame: 2.5 year
The relationship between vitamin D supplementation and cardiovascular disease.
Time frame: 2.5 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2011.
- Derived from this study: PubMed 22586483Gepner AD, Ramamurthy R, Krueger DC, Korcarz CE, Binkley N, Stein JH. A prospective randomized controlled trial of the effects of vitamin D supplementation on cardiovascular disease risk. PLoS One. 2012;7(5):e36617. doi: 10.1371/journal.pone.0036617. Epub 2012 May 7.
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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.
Neil Binkley, MD principal investigator
University of Wisconsin - Institute on Aging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol (vitamin D3) in people with Vitamin D Insufficiency and Vitamin D Deficiency, 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 7 inclusion and 13 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 Nov 2011. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the primary outcome is the proportion of postmenopausal women with D inadequacy defined by current consensus as a serum 25(OH)D < 30 ng/ml. (time frame: 2.5 years). 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 NCT00690417, 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 Nov 2011.