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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01090206
First received: March 16, 2010
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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

  Eligibility

Ages Eligible for Study:   2 Years to 21 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01090206

Locations
United States, Virginia
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
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov 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:
Hemophilia
Vitamin D

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

ClinicalTrials.gov processed this record on September 22, 2014