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

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Hemophilia B; Vitamin D Deficiency; Hemophilia A

Treatments: Dietary Supplement: Vitamin D and calcium

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01090206

PT 104212

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 2 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Hemophilia, Vitamin D deficiency

Other group

Description:

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

Treatment:

Dietary Supplement: Vitamin D and calcium