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

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ClinicalTrials.gov Identifier: NCT01090206
Recruitment Status : Completed
First Posted : March 19, 2010
Last Update Posted : April 29, 2016
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 21 Years   (Child, Adult)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov 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:
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
Bone Density Conservation Agents