BurnPhase 1NCT00285090
Bone Mineral Density, Body Composition and Growth Following Severe Burn Injury
A Phase 1 study testing Calcium, Vitamin D, Calcium,Vitamin D and Calcium, VitaminD in people with Burn and Growth, run by Kathy Prelack, PhD, RD at 1 site in United States.
Trial summary
The purpose of this study is two-fold. The first is to establish that bone mineral density is diminished among children admitted to this regional burn center as compared to healthy non-burned children. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Burn, Growth, Malnutrition
- What is being tested?
- Calcium, Vitamin D, Calcium,Vitamin D and Calcium, VitaminD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Feb 2007
- Phase
- Phase 1
- 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 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patient is between ages 4 and 18 at the time of study Patients must be of Black, White or Hispanic descent Patient has sustained a 30% or greater total body surface area burn Patient is enrolled ≤ 21 days of admission to the acute unit Patient is hemodynamically stable Patient does not have a history of osteopenia Inclusion criteria for reconstructive patients Child is between ages 4 to 18 Patients have sustained a 30% or greater tbsa in the last 10 years Patients must be of Black, White or Hispanic descent Live in Northeastern USA Inclusion criteria for healthy children Child is between ages 4 to 18 Patients must be of Black, White or Hispanic descent Live in Northeastern USA Child is capable of cooperating during measurement
Who cannot join
- Underlying complicating disorder that manifests in bone demineralization Patient or child is not expected to return to the hospital for additional follow-up or care
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Burns Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this study is two-fold. The first is to establish that bone mineral density is diminished among children admitted to this regional burn center as compared to healthy non-burned children. The second purpose of this study is to examine the short and long-term effects of calcium and vitamin D supplementation in on bone metabolism and accrual in children who have been burned.
Specific Aims: 1) To measure bone mineral content and bone mineral density and their change during growth in convalescent burned children admitted to a regional burn center and to compare them to normal, healthy children.; 2) To measure lean body mass, fat mass, total body water in convalescent burned children admitted to a regional burn center and compare them to normal, healthy children with focus on how these components of body composition relate to indices of bone mineral content and density; 3) To identify alterations in bone metabolism and calcium and vitamin D homeostasis following burn injury and relate these to bone mineral density in burned children; 4) To test the effect of short term calcium and vitamin D supplementation on improving bone mineral density, bone mineral content, and indices of calcium and vitamin D metabolism in acutely burned children.
Read the detailed description
The 60 acute patients will be randomized into 4 groups. Acute patients must be enrolled within 3 weeks of their admission to be eligible for study. Treatment is defined as provision of a supplement of 1000 mg elemental calcium with 400 IU of vitamin D daily as available in our standard hospital formulary and deemed appropriate by the pharmacist. Group 1 will take the supplement of from the day of enrollment in the study to the time of wound closure. Each group will consist of 15 patients. Upon enrollment into the study, 10 mL of blood will be obtained to measure baseline 25 and 1,25 vitamin D, parathyroid hormone, alkaline phosphatase, vitamin D binding protein, tumor necrosis factor, and IL-6 . The patients will be randomized into one of 4 groups: the early treatment group (Group 1), late treatment group (Group 2), total treatment group (Group 3) and the no treatment group (Group 4). Group 1 will take a supplement of 1000 mg calcium with 400 IU of vitamin D daily during their early acute phase of care (from the day of enrollment in the study until the time of wound closure). Group 2 will take the supplement during their rehabilitation phase of care (from the time of wound closure to the time of discharge). Group 3 will take the supplement for the entire duration of their stay (from the time of enrollment into the study to the time of discharge). Group 4 will receive no supplement. Patients who have a DXA scan of less than -2 SD units and who are in a group that is not receiving a supplement at that time (Groups 1 or 4), will begin supplementation (1000 mg calcium and 400 international units vitamin D) as part of routine care. They will remain in the study for monitoring and reporting of results. Blood levels as described above for baseline assessment will be repeated every 4 weeks for all acute patients during their initial hospital admission. At the time of wound closure, all acute patients will have their bone mineral content, bone mineral density, lean body mass, fat mass and total body water measured. This will be repeated immediately prior to discharge and at their next 2 planned reconstructive admissions (approximately 6 months to 1 year; and again at 2 years). A 10 mL blood draw to measure biochemical indices as described above will be obtained during these repeat hospital admissions as well.
- Conditions
- Burn, Growth, Malnutrition
- Being tested
- Calcium, Vitamin D, Calcium,Vitamin D, Calcium, VitaminD, Sugar Pill
- Keywords
- Burn Injury, Calcium, Vitamin D, Bone Mineral Density
- Medical subject headings
- Burns, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium, Vitamin DDietary supplement
Calcium,Vitamin DDietary supplement
Calcium, VitaminDDietary supplement
Sugar PillOther
| Study group | Role | What they receive |
|---|---|---|
| Early Treatment | Experimental | Not described Receives: Dietary Supplement: Calcium, Vitamin D |
| LateTreatment | Experimental | Not described Receives: Dietary Supplement: Calcium,Vitamin D |
| Total Treatment | Experimental | Not described Receives: Dietary Supplement: Calcium, VitaminD |
| No Treatment | Placebo comparator | Not described Receives: Other: Sugar Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Measured: 2 mos, 6 mos (acute), then Annual
Biochemical Indicators of Vitamin D and calcium status
Measured: every 4 weeks (acute), then annual
Growth
Measured: Annual
Secondary outcomes (1)
Lean Body Mass
Measured: 2 mos, 6 mos (acute), then annual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startFeb 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Why it stopped: Lack of volunteers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kathy Prelack, PhD, RD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kathy Prelack, PhD, RD, Shriners Hospitals for Children
- Investigators
- Kathrina Prelack, PhD, Principal investigator, Shriners Burns Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00285090
- Sponsor's protocol ID
- 2004-P-001850/4
- Status last verified
- Dec 2011
- First submitted
- 31 Jan 2006
- Last updated
- 20 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Mineral Density, Body Composition and Growth Following Severe Burn Injury
- ClinicalTrials.gov ID
- NCT00285090
- Acronym / sponsor ID
- 2004-P-001850/4
- Conditions
- Burn, Growth, Malnutrition
- Keywords
- Burn Injury, Calcium, Vitamin D, Bone Mineral Density
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of volunteers
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kathy Prelack, PhD, RDUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 1 Feb 2006 (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.
The purpose of this study is two-fold. The first is to establish that bone mineral density is diminished among children admitted to this regional burn center as compared to healthy non-burned children. The second purpose of this study is to examine the short and long-term effects of calcium and vitamin D supplementation in on bone metabolism and accrual in children who have been burned.
Specific Aims: 1) To measure bone mineral content and bone mineral density and their change during growth in convalescent burned children admitted to a regional burn center and to compare them to normal, healthy children.; 2) To measure lean body mass, fat mass, total body water in convalescent burned children admitted to a regional burn center and compare them to normal, healthy children with focus on how these components of body composition relate to indices of bone mineral content and density; 3) To identify alterations in bone metabolism and calcium and vitamin D homeostasis following burn injury and relate these to bone mineral density in burned children; 4) To test the effect of short term calcium and vitamin D supplementation on improving bone mineral density, bone mineral content, and indices of calcium and vitamin D metabolism in acutely burned children.
Detailed description
The 60 acute patients will be randomized into 4 groups. Acute patients must be enrolled within 3 weeks of their admission to be eligible for study. Treatment is defined as provision of a supplement of 1000 mg elemental calcium with 400 IU of vitamin D daily as available in our standard hospital formulary and deemed appropriate by the pharmacist. Group 1 will take the supplement of from the day of enrollment in the study to the time of wound closure. Each group will consist of 15 patients. Upon enrollment into the study, 10 mL of blood will be obtained to measure baseline 25 and 1,25 vitamin D, parathyroid hormone, alkaline phosphatase, vitamin D binding protein, tumor necrosis factor, and IL-6 . The patients will be randomized into one of 4 groups: the early treatment group (Group 1), late treatment group (Group 2), total treatment group (Group 3) and the no treatment group (Group 4). Group 1 will take a supplement of 1000 mg calcium with 400 IU of vitamin D daily during their early acute phase of care (from the day of enrollment in the study until the time of wound closure). Group 2 will take the supplement during their rehabilitation phase of care (from the time of wound closure to the time of discharge). Group 3 will take the supplement for the entire duration of their stay (from the time of enrollment into the study to the time of discharge). Group 4 will receive no supplement. Patients who have a DXA scan of less than -2 SD units and who are in a group that is not receiving a supplement at that time (Groups 1 or 4), will begin supplementation (1000 mg calcium and 400 international units vitamin D) as part of routine care. They will remain in the study for monitoring and reporting of results. Blood levels as described above for baseline assessment will be repeated every 4 weeks for all acute patients during their initial hospital admission. At the time of wound closure, all acute patients will have their bone mineral content, bone mineral density, lean body mass, fat mass and total body water measured. This will be repeated immediately prior to discharge and at their next 2 planned reconstructive admissions (approximately 6 months to 1 year; and again at 2 years). A 10 mL blood draw to measure biochemical indices as described above will be obtained during these repeat hospital admissions as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early Treatment | Experimental | Dietary Supplement: Calcium, Vitamin D |
| LateTreatment | Experimental | Dietary Supplement: Calcium,Vitamin D |
| Total Treatment | Experimental | Dietary Supplement: Calcium, VitaminD |
| No Treatment | Placebo comparator | Other: Sugar Pill |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patient is between ages 4 and 18 at the time of study Patients must be of Black, White or Hispanic descent Patient has sustained a 30% or greater total body surface area burn Patient is enrolled ≤ 21 days of admission to the acute unit Patient is hemodynamically stable Patient does not have a history of osteopenia Inclusion criteria for reconstructive patients Child is between ages 4 to 18 Patients have sustained a 30% or greater tbsa in the last 10 years Patients must be of Black, White or Hispanic descent Live in Northeastern USA Inclusion criteria for healthy children Child is between ages 4 to 18 Patients must be of Black, White or Hispanic descent Live in Northeastern USA Child is capable of cooperating during measurement
Key exclusion criteria (1 listed)
- Underlying complicating disorder that manifests in bone demineralization Patient or child is not expected to return to the hospital for additional follow-up or care
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 |
|---|---|---|
| Calcium, Vitamin D | Dietary supplement | Early Treatment |
| Calcium,Vitamin D | Dietary supplement | LateTreatment |
| Calcium, VitaminD | Dietary supplement | Total Treatment |
| Sugar Pill | Other | No Treatment |
Primary outcome
Bone mineral density
Time frame: 2 mos, 6 mos (acute), then Annual
Biochemical Indicators of Vitamin D and calcium status
Time frame: every 4 weeks (acute), then annual
Growth
Time frame: Annual
1 secondary outcome
Lean Body Mass
Time frame: 2 mos, 6 mos (acute), then annual
Results and safety
The study was stopped early (reason given: Lack of volunteers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2011.
Related trials for Burn
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
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.
Kathrina Prelack, PhD principal investigator
Shriners Burns Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Calcium, Vitamin D, Calcium,Vitamin D and Calcium, VitaminD in people with Burn and Growth, run by Kathy Prelack, PhD, RD 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 1 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: stopped early, as of the sponsor's last update on 20 Dec 2011. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of volunteers). Results are not available in the source record.
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?
Bone mineral density (time frame: 2 mos, 6 mos (acute), then Annual). The study lists 3 primary outcomes in all. 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 20 Dec 2011.