Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Virginia Commonwealth University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01090206
First received: March 16, 2010
Last updated: February 21, 2012
Last verified: March 2010
History of Changes
  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: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation Between Vitamin D Status and Bone Mineral Density in Patients With Hemophilia

Resource links provided by NLM:

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

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: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hemophilia, Vitamin D deficiency
  1. Hemophilia, Rickets
  2. Hemophilia, Vitamin D deficient
  3. Hemophilia, Normal Vitamin D
 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
Sampling Method:   Non-Probability Sample
Study Population

Boys with Hemophilia A or B, ages 2 years to 21 years - no therapeutic Vitamin D or calcium supplementation 3 months prior to study entry

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 Recruiting
Richmond, Virginia, United States, 23298
Contact: Melinda Nolte, RN     804-828-5531     mnolte@vcu.edu    
Contact: Gita Massey, MD     804-828-9605     GMassey2@mcvh-vcu.edu    
Sub-Investigator: Madhu Gowda, MD            
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: February 21, 2012
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 May 23, 2013