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

This study has been completed.

Sponsor:

Collaborator:

CSL Behring

Information provided by (Responsible Party):

Virginia Commonwealth University

ClinicalTrials.gov Identifier:

NCT01090206

First received: March 16, 2010

Last updated: April 27, 2016

Last verified: April 2016

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:	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:

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Bone Density Hemophilia Minerals Vitamin D

Drug Information available for: Vitamin D

Genetic and Rare Diseases Information Center resources: Hemophilia Hemophilia A Hemophilia B

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 ]


Enrollment:	20
Study Start Date:	March 2010
Study Completion Date:	March 2015
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Hemophilia, Vitamin D deficiency Hemophilia, Rickets - Vitamin D per endocrine consult Hemophilia, Vitamin D deficient - Vitamin D 2000 units daily plus calcium 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 (Child, Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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:	April 27, 2016
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 27, 2016

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