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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01090206
Recruitment Status : Completed
First Posted : March 19, 2010
Last Update Posted : April 29, 2016
CSL Behring
Information provided by (Responsible Party):
Virginia Commonwealth University

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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 : March 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2015

Arm Intervention/treatment
Hemophilia, Vitamin D deficiency
  1. Hemophilia, Rickets - Vitamin D per endocrine consult
  2. Hemophilia, Vitamin D deficient - Vitamin D 2000 units daily plus calcium
  3. Hemophilia, Normal Vitamin D - no intervention - observation only
Dietary Supplement: Vitamin D and calcium
Doses will be based on Vitamin D levels

Primary Outcome Measures :
  1. Correlate between Vitamin D deficiency, low bone mass and lack of weight bearing physical activity [ Time Frame: 1year ]

Secondary Outcome Measures :
  1. Determine bone mass (density) in hemophilia patients [ Time Frame: 1 yr ]
  2. establish dose and duration of treatment with vitamin D [ Time Frame: 1 yr ]

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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01090206

United States, Virginia
Virginia Commonwealth University Health System
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
CSL Behring
Principal Investigator: Gita V Massey, M.D. Virginia Commonwealth University

Responsible Party: Virginia Commonwealth University Identifier: NCT01090206     History of Changes
Other Study ID Numbers: PT 104212
First Posted: March 19, 2010    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016

Keywords provided by Virginia Commonwealth University:
Vitamin D

Additional relevant MeSH terms:
Hemophilia A
Vitamin D Deficiency
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Deficiency Diseases
Nutrition Disorders
Genetic Diseases, X-Linked
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents