- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00887666
Pilot Study: Hypovitaminosis D, Hyperparathyroidism and Hypomagnesemia in Patients With Congestive Heart Failure
April 14, 2017 updated by: State University of New York - Downstate Medical Center
People with heart failure may have low magnesium and low vitamin D levels.
They may also have abnormally high levels of parathyroid hormones.
Magnesium and vitamin D are important chemicals that are not routinely measured in blood tests.
We are studying how many people with heart failure have low levels of magnesium and vitamin D. We are also studying how many people with heart failure have overactive parathyroid glands and if that is related to their vitamin D levels.
Study Overview
Status
Completed
Detailed Description
This is a single-encounter crossectional prevalence study in which demographic information, health opinion surveys and labwork are all obtained at one visit.
There are no follow up visits, however, if abnormal lab results are discovered, participants will be notified via US mail.
Study Type
Observational
Enrollment (Actual)
48
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Brooklyn, New York, United States, 11203
- SUNY downstate Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
People with congestive heart failure
Description
Inclusion Criteria:
- congestive heart failure
Exclusion Criteria:
- pregnant
- hospitalized within one month
- taking calcium, vitamin D or magnesium supplements
- proteinuria > 1g/24h
- creatinine clearance <35 (MDRD)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalence of hypovitaminosis D, Hyperparathyroidism, Hypomagnesemia in our cohort of CHF patients
Time Frame: One year
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mariana Markell, MD, State University of New York - Downstate Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
April 23, 2009
First Submitted That Met QC Criteria
April 23, 2009
First Posted (Estimate)
April 24, 2009
Study Record Updates
Last Update Posted (Actual)
April 18, 2017
Last Update Submitted That Met QC Criteria
April 14, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Metabolic Diseases
- Endocrine System Diseases
- Nutrition Disorders
- Musculoskeletal Diseases
- Parathyroid Diseases
- Deficiency Diseases
- Malnutrition
- Bone Diseases
- Bone Diseases, Metabolic
- Calcium Metabolism Disorders
- Heart Failure
- Hyperparathyroidism
- Vitamin D Deficiency
- Rickets
- Avitaminosis
Other Study ID Numbers
- 07-121
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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