Correlation Between Vitamin D Status and Bone Mineral Den... | NCT01090206

Studies
Correlation Between Vitamin D Status and Bone Mineral Density in Patients With Hemophilia

NCT01090206

Sponsor

Virginia Commonwealth University

Status

Completed

Last Update Posted

Apr 29, 2016Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Hemophilia A
Hemophilia B
Vitamin D Deficiency

Interventions

Vitamin D and calcium

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 2016

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

Mar 2010

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2015Actual

First Submitted Date

Mar 16, 2010

First Submission Date that Met QC Criteria

Mar 17, 2010

First Posted Date

Mar 19, 2010Estimated

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 27, 2016

Last Update Posted Date

Apr 29, 2016Estimated

Name	Class
CSL Behring	INDUSTRY

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

Study will look at baseline Vitamin D levels, calcium, albumin, liver enzymes, testosterone, osteocalcin, urine N telopeptides, bone mineral density, nutritional assessment and physical activity assessment of boys with hemophilia A or B (ages 2-20 yrs). Patients with low vitamin D levels will receive therapeutic doses of Vitamin D. At end of one year follow up studies will be repeated.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hemophilia, Vitamin D deficiency	Other	Hemophilia, Rickets - Vitamin D per endocrine consult Hemophilia, Vitamin D deficient - Vitamin D 2000 units daily plus calcium Hemophilia, Normal Vitamin D - no intervention - observation only	Dietary Supplement: Vitamin D and calcium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D and calcium	Dietary Supplement	Doses will be based on Vitamin D levels	Hemophilia, Vitamin D deficiency

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlate between Vitamin D deficiency, low bone mass and lack of weight bearing physical activity		1year

Secondary Outcomes

Measure	Description	Time Frame
Determine bone mass (density) in hemophilia patients		1 yr
establish dose and duration of treatment with vitamin D		1 yr

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical diagnosis of Hemophilia A or B
ages 2-21 years

Exclusion Criteria:

therapeutic vitamin D or calcium supplementation within 3 months of study entry

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gita V Massey, M.D.	Virginia Commonwealth University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Commonwealth University Health System		Richmond	Virginia	23298	United States

Condition Browse Module

MeSH Terms

ID	Term
D006467	Hemophilia A
D002836	Hemophilia B
D014808	Vitamin D Deficiency

Ancestor Terms

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014807	Vitamin D
D002118	Calcium

Ancestor Terms

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided