Postmenopausal WomenNCT00235586
Vitamin D Deficiency: Bone Loss and Vascular Dysfunction
A study testing 10 vit. D deficient subjects take vit. D for 3 months. in people with Postmenopausal Women, run by University of Kansas at 1 site in United States.
Trial summary
To learn if there is a connection between low vitamin D level and hardening of the arteries. Read more about this study
- Who is it for?
- Ages 50 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Women
- What is being tested?
- 10 vit. D deficient subjects take vit. D for 3 months.
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Sep 2007
- 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 50 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females ages 50-70 with ability to give informed consent
- One year past last menstrual period
- 20 women with Vitamin D levels < 15 mg/ml
- 20 women with Vitamin D levels > 30 mg/ml
Who cannot join
- women receiving hormone replacement therapy
- women receiving medication known to effect vascular compliance, including anti-hypertension medications
- subjects receiving therapy for osteoporosis
- hyperthyroidism
- untreated hypothyroidism
- history of metabolic bone disease
Show all 11Show fewer
- current or previous use of medications known to accelerate bone loss
- chronic liver disease
- chronic renal disease
- diabetes mellitus
- obesity, BMI > 24
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
To learn if there is a connection between low vitamin D level and hardening of the arteries.
Read the detailed description
Osteoporosis and vascular disease are two of the most common disorders affecting postmenopausal women. A potential association, beyond aging, has long been speculated. Our previous study revealed evidence of loss of vascular compliance in postmenopausal women with lower bone density, suggesting women with lower bone density had "stiffer" blood vessels. This proposal further investigates that association and a potential role of vitamin D deficiency as a possible common link between both bone loss and "hardening of the arteries".
- Conditions
- Postmenopausal Women
- Being tested
- 10 vit. D deficient subjects take vit. D for 3 months.
- Keywords
- vitamin D deficiency postmenopausal women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 vit. D deficient subjects take vit. D for 3 months.Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine if differences exist in vascular compliance and carotid artery intima media thickness between individuals with normal and low vitamin D levels
to evaluate correlation of markers of vascular disease and boen disease between individuals with normal and low vitamin D
to quantify the effect of Vitamin D replacement on vascular compliance and markers of bone loss and vascular disease.
Secondary outcomes (1)
Vitamin D at the end of 3 months of supplementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startApr 2004
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal WomenStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Osteoporosis Foundation
- Investigators
- Leland Graves, III, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235586
- Sponsor's protocol ID
- 9248
- Status last verified
- Sep 2007
- First submitted
- 6 Oct 2005
- Last updated
- 20 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Deficiency: Bone Loss and Vascular Dysfunction
- ClinicalTrials.gov ID
- NCT00235586
- Acronym / sponsor ID
- 9248
- Conditions
- Postmenopausal Women
- Keywords
- vitamin D deficiency postmenopausal women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- National Osteoporosis Foundation
- Study start
- Apr 2004
- Study completion
- Sep 2007 (actual)
- First posted
- 10 Oct 2005 (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.
To learn if there is a connection between low vitamin D level and hardening of the arteries.
Detailed description
Osteoporosis and vascular disease are two of the most common disorders affecting postmenopausal women. A potential association, beyond aging, has long been speculated. Our previous study revealed evidence of loss of vascular compliance in postmenopausal women with lower bone density, suggesting women with lower bone density had "stiffer" blood vessels. This proposal further investigates that association and a potential role of vitamin D deficiency as a possible common link between both bone loss and "hardening of the arteries".
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Females ages 50-70 with ability to give informed consent
- One year past last menstrual period
- 20 women with Vitamin D levels < 15 mg/ml
- 20 women with Vitamin D levels > 30 mg/ml
Key exclusion criteria (11 listed)
- women receiving hormone replacement therapy
- women receiving medication known to effect vascular compliance, including anti-hypertension medications
- subjects receiving therapy for osteoporosis
- hyperthyroidism
- untreated hypothyroidism
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 |
|---|---|---|
| 10 vit. D deficient subjects take vit. D for 3 months. | Procedure or surgery | – |
Primary outcome
to determine if differences exist in vascular compliance and carotid artery intima media thickness between individuals with normal and low vitamin D levels
to evaluate correlation of markers of vascular disease and boen disease between individuals with normal and low vitamin D
to quantify the effect of Vitamin D replacement on vascular compliance and markers of bone loss and vascular disease.
1 secondary outcome
Vitamin D at the end of 3 months of supplementation.
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 20 Sep 2007.
Related trials for Postmenopausal Women
Recruiting
Methylation Profiling in Self-samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 1/2
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
Not yet recruiting
A Clinical Trial to Evaluate the Effects of the NeuEve Dryness Treatment Kit on Vaginal Health, Comfort, and Quality of Life in Postmenopausal Women
Relieves Vaginal Dryness / Improves Self-Lubrication, Improves Strength & Elasticity of Vagina (Aka Collagen and Elastin)
Enrolling by invitation
THE EFFECT OF SEXUAL COUNSELING BASED ON THE EXPLISSIT MODEL ON SEXUAL FUNCTION, MARITAL ADJUSTMENT, AND QUALITY OF SEXUAL LIFE IN POSTMENOPAUSAL WOMEN
Sexual and Reproductive Health, Menopausal and Postmenopausal Women
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.
Leland Graves, III, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 vit. D deficient subjects take vit. D for 3 months. in people with Postmenopausal Women, run by University of Kansas 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 4 inclusion and 11 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 20 Sep 2007. 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.
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?
to determine if differences exist in vascular compliance and carotid artery intima media thickness between individuals with normal and low vitamin D levels. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2007.