BurnsPhase 1VitaminDNCT00536276
Evaluation of Vitamin D Status in Children With Acute Burns
A Phase 1 study testing Vitamin D2 and Vitamin D3 in people with Burns and Bone Demineralization, run by Shriners Hospitals for Children at 1 site in United States.
Trial summary
To see which vitamin D supplement (D2 vs D3) is most beneficial in burned children. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Burns, Bone Demineralization
- What is being tested?
- Vitamin D2 and Vitamin D3
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Apr 2011
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Child is > 6 months of age but < 19 years old
- Burn injury > 30% total body surface area
- Admitted to SHC within 4 days of injury
- Attending physician decision that patient is likely to survive
- Parents or legal guardian give informed consent along with assent of the child as applicable
Who cannot join
- Attending physician decision that patient is not likely to survive
- Prior history of anticonvulsant or glucocorticoid use, gastric/bowel resection, parathyroid disease, liver disease, chronic renal failure or prior pharmacologic vitamin D use (>1000 IU/D)
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospital for Children
Cincinnati, Ohio, 45229
About this study
Official title: Vitamin D Deficiency in Acutely Injured Pediatric Burn Patients: Incidence, Etiology, Metabolic Sequelae and Prevention
To see which vitamin D supplement (D2 vs D3) is most beneficial in burned children.
Read the detailed description
The purpose of this study is to follow up our descriptive observations with a prospective randomized double blinded study to verify our clinical perception that hypovitaminosis D is prevalent postburn and to evaluate whether therapeutic supplementation will enhance specific primary outcome measures during burn convalescence.
- Conditions
- Burns, Bone Demineralization
- Being tested
- Vitamin D2, Vitamin D3
- Keywords
- vitamin D
- Medical subject headings
- Burns, Bone Demineralization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D2Dietary supplement
Also called ergocalciferol
Daily enteral dose of 100IU/kg
Vitamin D3Dietary supplement
Also called cholecalciferol
Daily enteral dose of 100IU/kg
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the effect of D2 vs D3 supplementation on serum 25-OH and 1,25 OH vitamin D levels
Measured: During acute phase postburn
Secondary outcomes (1)
Identify the most efficacious vitamin D analogue in terms of preventing deterioration of bone markers
Measured: During acute phase postburn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2007 (estimated)
- Study startMar 2003
- Primary completionDec 2009
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Gottschlich, Shriners Hospitals for Children
- Investigators
- Michele M Gottschlich, PhD, RD, CNSD, Principal investigator, Shriners Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536276
- Sponsor's protocol ID
- 01-9-26-1
- Acronym
- VitaminD
- Status last verified
- May 2012
- First submitted
- 25 Sep 2007
- Last updated
- 9 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gottschlich MM, Mayes T, Khoury J, Warden GD. Hypovitaminosis D in acutely injured pediatric burn patients. J Am Diet Assoc. 2004 Jun;104(6):931-41, quiz 1031. doi: 10.1016/j.jada.2004.03.020.
PubMed 15175591Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
PubMed 33305842
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Deficiency in Acutely Injured Pediatric Burn Patients: Incidence, Etiology, Metabolic Sequelae and Prevention
- ClinicalTrials.gov ID
- NCT00536276
- Acronym / sponsor ID
- VitaminD / 01-9-26-1
- Conditions
- Burns, Bone Demineralization
- Keywords
- vitamin D
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 27 Sep 2007 (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.
To see which vitamin D supplement (D2 vs D3) is most beneficial in burned children.
Detailed description
The purpose of this study is to follow up our descriptive observations with a prospective randomized double blinded study to verify our clinical perception that hypovitaminosis D is prevalent postburn and to evaluate whether therapeutic supplementation will enhance specific primary outcome measures during burn convalescence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Child is > 6 months of age but < 19 years old
- Burn injury > 30% total body surface area
- Admitted to SHC within 4 days of injury
- Attending physician decision that patient is likely to survive
- Parents or legal guardian give informed consent along with assent of the child as applicable
Key exclusion criteria (2 listed)
- Attending physician decision that patient is not likely to survive
- Prior history of anticonvulsant or glucocorticoid use, gastric/bowel resection, parathyroid disease, liver disease, chronic renal failure or prior pharmacologic vitamin D use (>1000 IU/D)
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 D2Also: ergocalciferolDaily enteral dose of 100IU/kg | Dietary supplement | – |
| Vitamin D3Also: cholecalciferolDaily enteral dose of 100IU/kg | Dietary supplement | – |
Primary outcome
Examine the effect of D2 vs D3 supplementation on serum 25-OH and 1,25 OH vitamin D levels
Time frame: During acute phase postburn
1 secondary outcome
Identify the most efficacious vitamin D analogue in terms of preventing deterioration of bone markers
Time frame: During acute phase postburn
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 9 May 2012.
- Results publication: PubMed 15175591Gottschlich MM, Mayes T, Khoury J, Warden GD. Hypovitaminosis D in acutely injured pediatric burn patients. J Am Diet Assoc. 2004 Jun;104(6):931-41, quiz 1031. doi: 10.1016/j.jada.2004.03.020.
- Derived from this study: PubMed 33305842Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
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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.
Michele M Gottschlich, PhD, RD, CNSD principal investigator
Shriners Hospital for Children
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 Vitamin D2 and Vitamin D3 in people with Burns and Bone Demineralization, run by Shriners Hospitals for Children 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 5 inclusion and 2 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 9 May 2012. 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.
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 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?
Examine the effect of D2 vs D3 supplementation on serum 25-OH and 1,25 OH vitamin D levels (time frame: During acute phase postburn). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00536276, which also lists 2 linked publications.
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 9 May 2012.