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

Primary Purpose

Hemophilia A, Hemophilia B, Vitamin D Deficiency

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vitamin D and calcium

About this trial

This is an interventional screening trial for Hemophilia A focused on measuring Hemophilia, Vitamin D

Eligibility Criteria

2 Years - 21 Years (Child, Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Virginia Commonwealth University Health System

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Hemophilia, Vitamin D deficiency

Arm Description

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

Outcomes

Primary Outcome Measures

Correlate between Vitamin D deficiency, low bone mass and lack of weight bearing physical activity

Secondary Outcome Measures

Determine bone mass (density) in hemophilia patients

establish dose and duration of treatment with vitamin D

Full Information

NCT ID

NCT01090206

First Posted

March 16, 2010

Last Updated

April 27, 2016

Sponsor

Virginia Commonwealth University

Collaborators

CSL Behring

1. Study Identification

Unique Protocol Identification Number

NCT01090206

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Virginia Commonwealth University

Collaborators

CSL Behring

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemophilia A, Hemophilia B, Vitamin D Deficiency

Keywords

Hemophilia, Vitamin D

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hemophilia, Vitamin D deficiency

Arm Type

Other

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D and calcium

Intervention Description

Doses will be based on Vitamin D levels

Primary Outcome Measure Information:

Title

Correlate between Vitamin D deficiency, low bone mass and lack of weight bearing physical activity

Time Frame

1year

Secondary Outcome Measure Information:

Title

Determine bone mass (density) in hemophilia patients

Time Frame

1 yr

Title

establish dose and duration of treatment with vitamin D

Time Frame

1 yr

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gita V Massey, M.D.

Organizational Affiliation

Virginia Commonwealth University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Virginia Commonwealth University Health System

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

12. IPD Sharing Statement

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

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