Type 1 Diabetes MellitusPhase 3NCT01029392
Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect of Supplementation on Insulin Requirements
A Phase 3 study testing Vitamin D in people with Type 1 Diabetes Mellitus, run by Corewell Health East at 1 site in United States.
Trial summary
Our objective is to demonstrate that providing supplemental vitamin D to children with new onset DM will significantly decrease the levels of HbA1c and insulin requirement by the following methods. 1. Identify how often vitamin D levels are low in patients with new onset Type 1 diabetes mellitus (DM). 2. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jun 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Newly diagnosed type I DM.
- Age <18 years
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect on Insulin Requirements After Supplementation With Vitamin D-A Pilot Study
Our objective is to demonstrate that providing supplemental vitamin D to children with new onset DM will significantly decrease the levels of HbA1c and insulin requirement by the following methods.
- Identify how often vitamin D levels are low in patients with new onset Type 1 diabetes mellitus (DM).
- Record the hemoglobin A1c (HbA1c) level (which reflects the average blood sugar level over the past few months) and document insulin requirements before and after vitamin supplementation is given.
Hypothesis: Maintaining vitamin D levels >30 ng/ml will decrease HbA1c and insulin requirements.
Read the detailed description
New onset type 1 DM patients who present at William Beaumont Hospital, Royal Oak or to the Pediatric Endocrine Clinic will be approached about the study at their presentation and time will be given for the patient and family to discuss and ask questions regarding the study. Patients will then be enrolled following informed consent. Glucose levels and insulin requirements will be monitored continuously from the faxed weekly logbooks from the point of diagnosis for 3 months (as standard practice for all newly diagnosed diabetic patients in our clinic). At the baseline visit a Vitamin D level will be drawn and frozen for 3 months prior to processing. .After 3 months vitamin D, calcium, alkaline phosphatase, phosphorus and other standard of care lab draws will be done. Approximately an additional 3 tsp of blood will be taken. All female subjects of child bearing potential will have a pregnancy test done. EMLA cream to anesthetize the area will be used prior to blood draw. A vitamin D level of <30 ng/ml is considered insufficient and the patient will then be given vitamin D supplement. The vitamin D level, calcium, alkaline phosphatase and phosphorus will be rechecked at 6 months (additional 3 tsp of blood) . Glucose levels and insulin requirements will be monitored continuously from the faxed weekly logbooks again for another 3 months.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Vitamin D
- Keywords
- Diabetes, Type I, Newly Diagnosis Type I Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called cholecalciferol
2000iu once a day
| Study group | Role | What they receive |
|---|---|---|
| Required Vitamin D | Experimental | Those children whose Vitamin D level was low (<30 ng/mL) are given Vitamin D supplementation Receives: Drug: Vitamin D |
| Normal Vitamin D | No intervention | Those children whose Vitamin D level was normal (50-80 ng/mL) did not receive Vitamin D supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c
Change in hemoglobin A1c calculated as a percentage change from baseline measurement
Measured: 6 months
Secondary outcomes (1)
Change in Insulin Requirements
Percentage change from baseline number of units of lantus insulin over 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 Diabetes MellitusStudies 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 3
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with clinically significantly low Vitamin D levels (\<30 ng/mL) were supplemented with Vitamin D and compared to patients with normal vitamin D levels (50-80 nG/mL).
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Gerrits, MD, Corewell Health East
- Investigators
- Peter Gerrits, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029392
- Sponsor's protocol ID
- 2009-189
- Status last verified
- Dec 2016
- First submitted
- 9 Dec 2009
- Last updated
- 17 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Vitamin D Deficiency in Type 1 Diabetes Mellitus and Effect on Insulin Requirements After Supplementation With Vitamin D-A Pilot Study
- ClinicalTrials.gov ID
- NCT01029392
- Acronym / sponsor ID
- 2009-189
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Diabetes, Type I, Newly Diagnosis Type I Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Dec 2009 (estimated)
- Results
- Posted 17 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our objective is to demonstrate that providing supplemental vitamin D to children with new onset DM will significantly decrease the levels of HbA1c and insulin requirement by the following methods.
- Identify how often vitamin D levels are low in patients with new onset Type 1 diabetes mellitus (DM).
- Record the hemoglobin A1c (HbA1c) level (which reflects the average blood sugar level over the past few months) and document insulin requirements before and after vitamin supplementation is given.
Hypothesis: Maintaining vitamin D levels >30 ng/ml will decrease HbA1c and insulin requirements.
Detailed description
New onset type 1 DM patients who present at William Beaumont Hospital, Royal Oak or to the Pediatric Endocrine Clinic will be approached about the study at their presentation and time will be given for the patient and family to discuss and ask questions regarding the study. Patients will then be enrolled following informed consent. Glucose levels and insulin requirements will be monitored continuously from the faxed weekly logbooks from the point of diagnosis for 3 months (as standard practice for all newly diagnosed diabetic patients in our clinic). At the baseline visit a Vitamin D level will be drawn and frozen for 3 months prior to processing. .After 3 months vitamin D, calcium, alkaline phosphatase, phosphorus and other standard of care lab draws will be done. Approximately an additional 3 tsp of blood will be taken. All female subjects of child bearing potential will have a pregnancy test done. EMLA cream to anesthetize the area will be used prior to blood draw. A vitamin D level of <30 ng/ml is considered insufficient and the patient will then be given vitamin D supplement. The vitamin D level, calcium, alkaline phosphatase and phosphorus will be rechecked at 6 months (additional 3 tsp of blood) . Glucose levels and insulin requirements will be monitored continuously from the faxed weekly logbooks again for another 3 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with clinically significantly low Vitamin D levels (<30 ng/mL) were supplemented with Vitamin D and compared to patients with normal vitamin D levels (50-80 nG/mL).
| Arm | Type | Receives |
|---|---|---|
| Required Vitamin D | Experimental | Drug: Vitamin DThose children whose Vitamin D level was low (<30 ng/mL) are given Vitamin D supplementation |
| Normal Vitamin D | No intervention | –Those children whose Vitamin D level was normal (50-80 ng/mL) did not receive Vitamin D supplementation |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Newly diagnosed type I DM.
- Age <18 years
Key exclusion criteria (1 listed)
- Pregnancy
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 DAlso: cholecalciferol2000iu once a day | Drug | Required Vitamin D |
Primary outcome
Change in Hemoglobin A1c
Time frame: 6 months
Change in hemoglobin A1c calculated as a percentage change from baseline measurement
1 secondary outcome
Change in Insulin Requirements
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No data sharing.
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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.
Peter Gerrits, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D in people with Type 1 Diabetes Mellitus, run by Corewell Health East 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 17 Apr 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Hemoglobin A1c (time frame: 6 months). 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 17 Apr 2017.