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

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01090206
• Collaborator: CSL Behring (Industry)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 60
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hemophilia A; Hemophilia B; Vitamin D Deficiency	Dietary Supplement: Vitamin D and calcium	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Correlation Between Vitamin D Status and Bone Mineral Density in Patients With Hemophilia
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Hemophilia, Vitamin D deficiency 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; Doses will be based on Vitamin D levels

Outcome Measures

Primary Outcome Measures

1. Correlate between Vitamin D deficiency, low bone mass and lack of weight bearing physical activity [1year]

Secondary Outcome Measures

1. Determine bone mass (density) in hemophilia patients [1 yr]

2. establish dose and duration of treatment with vitamin D [1 yr]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 21 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Commonwealth University Health System	Richmond	Virginia	United States	23298

Sponsors and Collaborators

• Virginia Commonwealth University
• CSL Behring

Investigators

• Principal Investigator: Gita V Massey, M.D., Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT01090206
• Other Study ID Numbers: PT 104212
• First Posted: Mar 19, 2010
• Last Update Posted: Apr 29, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Virginia Commonwealth University: Hemophilia; Vitamin D
• Additional relevant MeSH terms: Hemophilia A; Hemophilia B; Vitamin D Deficiency; Vitamin D; Calcium

Study Results

No Results Posted as of Apr 29, 2016