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

March 16, 2010
January 6, 2014
March 2010
March 2013   (final data collection date for primary outcome measure)
Correlate between Vitamin D deficiency, low bone mass and lack of weight bearing physical activity [ Time Frame: 1year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01090206 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Correlation Between Vitamin D Status and Bone Mineral Density in Patients With Hemophilia
Correlation Between Vitamin D Status and Bone Mineral Density in Patients With Hemophilia

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
  • Hemophilia A
  • Hemophilia B
  • Vitamin D Deficiency
Dietary Supplement: Vitamin D and calcium
Doses will be based on Vitamin D levels
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
Intervention: Dietary Supplement: Vitamin D and calcium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
March 2014
March 2013   (final data collection date for primary outcome measure)

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
Male
2 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01090206
PT 104212
No
Virginia Commonwealth University
Virginia Commonwealth University
CSL Behring
Principal Investigator: Gita V Massey, M.D. Virginia Commonwealth University
Virginia Commonwealth University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP