- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01090206
Correlation Between Vitamin D Status and Bone Mineral Density in Patients With Hemophilia
April 27, 2016 updated by: Virginia Commonwealth University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Hemophilia, Vitamin D deficiency
|
Doses will be based on Vitamin D levels
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlate between Vitamin D deficiency, low bone mass and lack of weight bearing physical activity
Time Frame: 1year
|
1year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine bone mass (density) in hemophilia patients
Time Frame: 1 yr
|
1 yr
|
establish dose and duration of treatment with vitamin D
Time Frame: 1 yr
|
1 yr
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gita V Massey, M.D., Virginia Commonwealth University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
March 16, 2010
First Submitted That Met QC Criteria
March 17, 2010
First Posted (Estimate)
March 19, 2010
Study Record Updates
Last Update Posted (Estimate)
April 29, 2016
Last Update Submitted That Met QC Criteria
April 27, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Hematologic Diseases
- Nutrition Disorders
- Blood Coagulation Disorders, Inherited
- Coagulation Protein Disorders
- Hemorrhagic Disorders
- Genetic Diseases, Inborn
- Genetic Diseases, X-Linked
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Blood Coagulation Disorders
- Hemophilia A
- Hemophilia B
- Vitamin D Deficiency
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Calcium
Other Study ID Numbers
- PT 104212
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hemophilia A
-
Christoph KönigsRoche Pharma AG; Chugai Pharma Germany GmbHRecruitingSevere Hemophilia A | Severe Hemophilia A With Inhibitor | Severe Hemophilia A Without InhibitorGermany
-
GWT-TUD GmbHHannover Medical School; Hoffmann-La RocheCompleted
-
Kathelijn FischerRadboud University Medical Center; University Medical Center Groningen; Maastricht... and other collaboratorsRecruitingAdolescent | Child | Hemophilia A With Inhibitor | Adult | Hemophilia A Without Inhibitor | Hemophilia A, SevereNetherlands
-
Hoffmann-La RocheActive, not recruitingSevere Hemophilia A | Moderate Hemophilia ABrazil, Germany, Italy, Spain, United States, Turkey, United Kingdom, Tunisia, Canada, Hungary, Morocco, Serbia
-
Catalyst BiosciencesCompletedHemophilia A | Hemophilia B | Hemophilia A With Inhibitor | Hemophilia B With Inhibitor | Hemophilia A Without Inhibitor | Hemophilia B Without InhibitorBulgaria, Russian Federation
-
JW PharmaceuticalRecruitingHemophilia A With Inhibitor | Hemophilia A Without InhibitorKorea, Republic of
-
PfizerCompletedFactor VIII Deficiency, Congenital | Hemophilia A, Congenital | Factor 8 Deficiency, Congenital | Autosomal Hemophilia A | Classic Hemophilia
-
BioMarin PharmaceuticalRecruitingHemophilia A With Inhibitor | Hemophilia A With Anti Factor VIIIUnited States, United Kingdom, Taiwan, Israel, Korea, Republic of, South Africa, Brazil, Italy, Germany
-
American Thrombosis and Hemostasis NetworkTakeda; CSL Behring; OctapharmaCompletedHemophilia A | Hemophilia B | Hemophilia | Hemophilia A With Inhibitor | Haemophilia | Hemophilia B With Inhibitor | Haemophilia A Without Inhibitor | Haemophilia B Without InhibitorUnited States
-
BayerCompletedHemophilia A; Hemophilia BIsrael
Clinical Trials on Vitamin D and calcium
-
National and Kapodistrian University of AthensNational Hellenic Research FoundationCompletedOsteopenia | Postmenopausal OsteopeniaGreece
-
Kathy Prelack, PhD, RDTerminatedMalnutrition | Growth | BurnUnited States
-
University of JenaCompleted
-
International Medical UniversityCompleted
-
Charite University, Berlin, GermanyCompletedOsteoporosis, PostmenopausalGermany
-
Chiang Mai UniversityNakornping Hospital; HIV-NAT, Thai Red Cross - AIDS Research CentreCompletedHIV Infection | Adverse Bone HealthThailand
-
Universität des SaarlandesCompletedNutritional Supplement ToxicityGermany
-
The Hospital for Sick ChildrenCompleted
-
Ioannis K. Triantafyllopoulos, MD,MSci,PhDCompletedOsteopenia | Postmenopausal Osteopenia
-
University Hospital, AngersCompleted