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

ClinicalTrials.gov processed this record on April 16, 2014