Hemophilia ANCT01090206
Correlation Between Vitamin D Status and Bone Mineral Density in Patients With Hemophilia
A study testing Vitamin D and calcium in people with Hemophilia A and Hemophilia B, run by Virginia Commonwealth University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 21 years, men only
- Conditions the study is for
- Hemophilia A, Hemophilia B, Vitamin D Deficiency
- What is being tested?
- Vitamin D and calcium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 21 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- clinical diagnosis of Hemophilia A or B
- ages 2-21 years
Who cannot join
- therapeutic vitamin D or calcium supplementation within 3 months of study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University Health System
Richmond, Virginia, 23298
About this study
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.
- Conditions
- Hemophilia A, Hemophilia B, Vitamin D Deficiency
- Being tested
- Vitamin D and calcium
- Keywords
- Hemophilia, Vitamin D
- Medical subject headings
- Hemophilia A, Hemophilia B, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D and calciumDietary supplement
Doses will be based on Vitamin D levels
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Vitamin D and calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate between Vitamin D deficiency, low bone mass and lack of weight bearing physical activity
Measured: 1year
Secondary outcomes (2)
Determine bone mass (density) in hemophilia patients
Measured: 1 yr
establish dose and duration of treatment with vitamin D
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2013
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- CSL Behring
- Responsible party
- Sponsor
- Investigators
- Gita V Massey, M.D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090206
- Sponsor's protocol ID
- PT 104212
- Status last verified
- Apr 2016
- First submitted
- 16 Mar 2010
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Vitamin D Status and Bone Mineral Density in Patients With Hemophilia
- ClinicalTrials.gov ID
- NCT01090206
- Acronym / sponsor ID
- PT 104212
- Conditions
- Hemophilia A, Hemophilia B, Vitamin D Deficiency
- Keywords
- Hemophilia, Vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- CSL Behring
- Study start
- Mar 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemophilia, Vitamin D deficiency | Other | Dietary Supplement: Vitamin D and calcium1. 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 |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- clinical diagnosis of Hemophilia A or B
- ages 2-21 years
Key exclusion criteria (1 listed)
- therapeutic vitamin D or calcium supplementation within 3 months of study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D and calciumDoses will be based on Vitamin D levels | Dietary supplement | Hemophilia, Vitamin D deficiency |
Primary outcome
Correlate between Vitamin D deficiency, low bone mass and lack of weight bearing physical activity
Time frame: 1year
2 secondary outcomes
Determine bone mass (density) in hemophilia patients
Time frame: 1 yr
establish dose and duration of treatment with vitamin D
Time frame: 1 yr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
Related trials for Hemophilia A
RecruitingPhase 1/2
A First-in Human Study of ARD001 in Healthy Volunteers and People With Hemophilia A
Hemophilia A, Healthy Adult Participants
RecruitingPhase 3
A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A
Haemophilia A
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
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RecruitingPhase 3
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
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RecruitingObservational study
An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A
Hemophilia A
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gita V Massey, M.D. principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D and calcium in people with Hemophilia A and Hemophilia B, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlate between Vitamin D deficiency, low bone mass and lack of weight bearing physical activity (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2016; AzTrials last refreshed its copy on 30 Oct 2026.