Pilot Study: Hypovitaminosis D, Hyperparathyroidism and H... | NCT00887666

Studies
Pilot Study: Hypovitaminosis D, Hyperparathyroidism and Hypomagnesemia in Patients With Congestive Heart Failure

NCT00887666

Sponsor

State University of New York - Downstate Medical Center

Status

Completed

Last Update Posted

Apr 18, 2017Actual

Enrollment

48Actual

Phase

Not provided

Conditions

Congestive Heart Failure
Hypovitaminosis D
Hyperparathyroidism

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Apr 23, 2009

First Submission Date that Met QC Criteria

Apr 23, 2009

First Posted Date

Apr 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2017

Last Update Posted Date

Apr 18, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of hypovitaminosis D, Hyperparathyroidism, Hypomagnesemia in our cohort of CHF patients		One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

People with congestive heart failure

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mariana Markell, MD	State University of New York - Downstate Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SUNY Downstate Medical Center		Brooklyn	New York	11203	United States

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D014808	Vitamin D Deficiency
D006961	Hyperparathyroidism

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001361	Avitaminosis
D003677	Deficiency Diseases

Browse Leaves

Not provided

Browse Branches

Not provided