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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090206
• Other study ID #: PT 104212
• Status: Completed
• Phase: N/A
• First received: March 16, 2010
• Last updated: April 27, 2016
• Start date: March 2010
• Est. completion date: March 2015

Study information

• Verified date: April 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2015
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 2 Years to 21 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia B
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D and calcium
Doses will be based on Vitamin D levels

Locations

Country	Name	City	State
United States	Virginia Commonwealth University Health System	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	CSL Behring

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlate between Vitamin D deficiency, low bone mass and lack of weight bearing physical activity		1year	No
Secondary	Determine bone mass (density) in hemophilia patients		1 yr	No
Secondary	establish dose and duration of treatment with vitamin D		1 yr	No