Trial record 6 of 368 for:    "hemophilia"

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

This study is ongoing, but not recruiting participants.
CSL Behring
Information provided by (Responsible Party):
Virginia Commonwealth University Identifier:
First received: March 16, 2010
Last updated: January 6, 2014
Last verified: January 2014

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 Intervention
Hemophilia A
Hemophilia B
Vitamin D Deficiency
Dietary Supplement: Vitamin D and calcium

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Correlation Between Vitamin D Status and Bone Mineral Density in Patients With Hemophilia

Resource links provided by NLM:

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Correlate between Vitamin D deficiency, low bone mass and lack of weight bearing physical activity [ Time Frame: 1year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine bone mass (density) in hemophilia patients [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
  • establish dose and duration of treatment with vitamin D [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2010
Estimated Study Completion Date: March 2014
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   2 Years to 21 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University Identifier: NCT01090206     History of Changes
Other Study ID Numbers: PT 104212
Study First Received: March 16, 2010
Last Updated: January 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Vitamin D

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Vitamin D Deficiency
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Deficiency Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hematologic Diseases
Hemorrhagic Disorders
Nutrition Disorders
Vitamin D
Bone Density Conservation Agents
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs processed this record on October 02, 2015