NCT01090206

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 29, 2016

Status Verified

April 1, 2016

Enrollment Period

3 years

First QC Date

March 16, 2010

Last Update Submit

April 27, 2016

Conditions

Hemophilia AHemophilia BVitamin D Deficiency

Keywords

HemophiliaVitamin D

Outcome Measures

Primary Outcomes (1)

  • Correlate between Vitamin D deficiency, low bone mass and lack of weight bearing physical activity

    1year

Secondary Outcomes (2)

  • Determine bone mass (density) in hemophilia patients

    1 yr

  • establish dose and duration of treatment with vitamin D

    1 yr

Study Arms (1)

Hemophilia, Vitamin D deficiency

OTHER

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

Dietary Supplement: Vitamin D and calcium

Interventions

Vitamin D and calciumDIETARY_SUPPLEMENT

Doses will be based on Vitamin D levels

Hemophilia, Vitamin D deficiency

Eligibility Criteria

Age2 Years - 21 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • clinical diagnosis of Hemophilia A or B
  • ages 2-21 years

You may not qualify if:

  • therapeutic vitamin D or calcium supplementation within 3 months of study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University Health System

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Hemophilia AHemophilia BVitamin D Deficiency

Interventions

Vitamin DCalcium

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-LinkedAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Gita V Massey, M.D.

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2010

First Posted

March 19, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2015

Last Updated

April 29, 2016

Record last verified: 2016-04

Locations

US(1)