Type 1 DiabetesPhase 2/3PCRNCT03046927
Vitamin D and Residual Beta-Cell Function in Type 1 Diabetes
A Phase 2/3 study testing Ergocalciferol in people with Type 1 Diabetes, run by Benjamin U. Nwosu, MD at 1 site in United States.
Trial summary
This project is designed to study the role of vitamin D supplementation on the honeymoon phase of type 1 diabetes in children who are on standardized insulin treatment. The results could lead to significant changes in the approach to the early phase of type 1 diabetes with a strong emphasis on prolonging the honeymoon… Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Ergocalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2017to 20 Apr 2021
- Phase
- Phase 2/3
- 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 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 10-21 years.
- Sex: male and female subjects will be enrolled.
- Tanner stage: I-V.
- T1D duration of <3 months (i.e., from first insulin injection) to ensure the inclusion of patients in PCR.
- Presence of at least one diabetes-associated autoantibody.
- Normal-weight, overweight-, and obese subjects with T1D
- Fasting serum C-peptide level of >0.1 nmol/L (0.3 ng/mL)1; or 2-hour post-meal stimulated C-peptide level of 0.2 nmol/L (≥0.6 ng/mL).
Who cannot join
- Subjects on weight altering medications, such as orlistat.
- Subjects with eating disorders
- Subjects on medications other than insulin that can affect blood glucose level.
- Subjects with 25-hydroxyvitamin D [25(OH)D] levels of >70 ng/mL, as this may lead to vitamin D toxicity in the study subjects.
- Subjects with systemic diseases other than T1D.
- Subjects with recurrent diabetic ketoacidosis (>2 episodes since the diagnosis of T1D or in the preceding 3 months); or >2 episodes of severe hypoglycemia in the preceding 3 mo.
Show all 9Show fewer
- Pregnant or breast-feeding female subjects.
- The receipt of any investigational drug within 6 months prior to this trial.
- Active malignant neoplasm.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
This project is designed to study the role of vitamin D supplementation on the honeymoon phase of type 1 diabetes in children who are on standardized insulin treatment. The results could lead to significant changes in the approach to the early phase of type 1 diabetes with a strong emphasis on prolonging the honeymoon phase by using vitamin D and maintaining these patients on a standardized insulin regimen. The overall goal is to reduce the long-term complications of type 1 diabetes.
Read the detailed description
Prolonging the duration of the partial clinical remission (PCR), or 'honeymoon' phase, of type 1 diabetes (T1D) improves glycemic control and reduces long-term complications. Recent studies suggest the exciting possibility that vitamin D supplementation, a safe and easy-to-implement therapy in children, may lengthen PCR and increase residual beta cell function (RBCF).
However, existing studies employed a suboptimal vitamin D dose or lacked a standardized insulin treatment protocol, precluding solid conclusions and preventing the field from moving forward with translation to clinical practice. This trial's rationale is to securely establish the effect of an adequate dose of vitamin D on PCR and RBCF.
We hypothesize that vitamin D will increase RBCF and prolong PCR. The primary aim is to determine the effect of adjunctive vitamin D on RBCF and PCR in youth with T1D maintained on a standardized insulin protocol. We propose a 12-month randomized, double-blind, placebo-controlled, parallel design trial of ergocalciferol vs. placebo in 40 subjects of 10-21 years with newly-diagnosed T1D. The primary outcome is the change over time in stimulated C-peptide (a measure of RBCF). Secondary outcomes include change over time in insulin-dose-adjusted-hemoglobin-A1c (HbA1c) (IDAA1C; a measure of PCR), HbA1c, and total daily dose of insulin. Mechanistic studies will explore whether beneficial effects of vitamin D are associated with increased GLP-1 levels or decreased inflammatory markers, and whether response to vitamin D is impacted by T1D-risk polymorphisms. If our hypotheses are true, these findings may completely alter the approach to the early management of T1D, with strong emphasis on prolonging the honeymoon phase using a readily available and easily affordable vitamin D while maintaining these patients on a standardized insulin treatment regimen.
- Conditions
- Type 1 Diabetes
- Being tested
- Ergocalciferol, Placebo
- Keywords
- Type 1 diabetes, vitamin D, honeymoon phase
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgocalciferolDrug
Also called Vitamin D
Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months
PlaceboOther
Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months
| Study group | Role | What they receive |
|---|---|---|
| Ergocalciferol | Experimental | Oral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D Receives: Drug: Ergocalciferol |
| Placebo | Placebo comparator | Oral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Beta-cell Function (RBCF)
Investigation of the effect of vitamin D on residual beta cell function (RBCF) in the first 12 months after the diagnosis of T1D by using stimulated C-peptide levels to quantify RBCF.
Measured: Baseline to 12 months at 3 months interval
Secondary outcomes (4)
Change in Percent of HbA1c From Baseline Over Time During Partial Clinical Remission (PCR)
Effect of vitamin D supplementation on glycemic control during the partial clinical remission phase as shown by the change in percent HbA1c from baseline across longitudinal measurements at 0, 3, 6, 9, and 12 months.
Measured: Baseline to 12 months
Glucagon-like Peptide-1 (GLP-1)
Investigation of the effect of vitamin D supplementation on GLP-1 during PCR.
Measured: Baseline to 12 months at 3 months interval
Vitamin D Binding Protein (VDBP)
Investigation of the effect of vitamin D supplementation on VDBP during PCR.
Measured: Baseline to 12 months at 3 months interval
Effect of Vitamin D Supplementation on the Duration of Partial Clinical Remission (PCR) of Type 1 Diabetes
Insulin dose-adjusted hemoglobin A1c (HbA1c) (IDAA1C)
Measured: Baseline to12 months 3 monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start19 Oct 2017
- Primary completion12 Apr 2021
- Study completion20 Apr 2021
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 DiabetesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 12-month randomized, double-blind, placebo-controlled, parallel design trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benjamin U. Nwosu, MD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Worcester, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor-investigator, Benjamin U. Nwosu, MD, University of Massachusetts, Worcester
- Investigators
- Benjamin U Nwosu, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046927
- Sponsor's protocol ID
- H00010550
- Other IDs
- 1R21DK113353
- Acronym
- PCR
- Status last verified
- Jun 2024
- First submitted
- 1 Feb 2017
- Last updated
- 10 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Residual Beta-Cell Function in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03046927
- Acronym / sponsor ID
- PCR / H00010550
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, vitamin D, honeymoon phase
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Benjamin U. Nwosu, MDUniversity, hospital or other
- Collaborators
- University of Massachusetts, Worcester, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Posted 10 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is designed to study the role of vitamin D supplementation on the honeymoon phase of type 1 diabetes in children who are on standardized insulin treatment. The results could lead to significant changes in the approach to the early phase of type 1 diabetes with a strong emphasis on prolonging the honeymoon phase by using vitamin D and maintaining these patients on a standardized insulin regimen. The overall goal is to reduce the long-term complications of type 1 diabetes.
Detailed description
Prolonging the duration of the partial clinical remission (PCR), or 'honeymoon' phase, of type 1 diabetes (T1D) improves glycemic control and reduces long-term complications. Recent studies suggest the exciting possibility that vitamin D supplementation, a safe and easy-to-implement therapy in children, may lengthen PCR and increase residual beta cell function (RBCF).
However, existing studies employed a suboptimal vitamin D dose or lacked a standardized insulin treatment protocol, precluding solid conclusions and preventing the field from moving forward with translation to clinical practice. This trial's rationale is to securely establish the effect of an adequate dose of vitamin D on PCR and RBCF.
We hypothesize that vitamin D will increase RBCF and prolong PCR. The primary aim is to determine the effect of adjunctive vitamin D on RBCF and PCR in youth with T1D maintained on a standardized insulin protocol. We propose a 12-month randomized, double-blind, placebo-controlled, parallel design trial of ergocalciferol vs. placebo in 40 subjects of 10-21 years with newly-diagnosed T1D. The primary outcome is the change over time in stimulated C-peptide (a measure of RBCF). Secondary outcomes include change over time in insulin-dose-adjusted-hemoglobin-A1c (HbA1c) (IDAA1C; a measure of PCR), HbA1c, and total daily dose of insulin. Mechanistic studies will explore whether beneficial effects of vitamin D are associated with increased GLP-1 levels or decreased inflammatory markers, and whether response to vitamin D is impacted by T1D-risk polymorphisms. If our hypotheses are true, these findings may completely alter the approach to the early management of T1D, with strong emphasis on prolonging the honeymoon phase using a readily available and easily affordable vitamin D while maintaining these patients on a standardized insulin treatment regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 12-month randomized, double-blind, placebo-controlled, parallel design trial
| Arm | Type | Receives |
|---|---|---|
| Ergocalciferol | Experimental | Drug: ErgocalciferolOral administration of 50,000 IU of ergocalciferol one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D |
| Placebo | Placebo comparator | Other: PlaceboOral administration of placebo one capsule per week for 2 months; and then once every 2 weeks for 10 months in 20 subjects of 10-21yr with newly diagnosed T1D |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age: 10-21 years.
- Sex: male and female subjects will be enrolled.
- Tanner stage: I-V.
- T1D duration of <3 months (i.e., from first insulin injection) to ensure the inclusion of patients in PCR.
- Presence of at least one diabetes-associated autoantibody.
Key exclusion criteria (9 listed)
- Subjects on weight altering medications, such as orlistat.
- Subjects with eating disorders
- Subjects on medications other than insulin that can affect blood glucose level.
- Subjects with 25-hydroxyvitamin D [25(OH)D] levels of >70 ng/mL, as this may lead to vitamin D toxicity in the study subjects.
- Subjects with systemic diseases other than T1D.
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 |
|---|---|---|
| ErgocalciferolAlso: Vitamin DEach subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months | Drug | Ergocalciferol |
| PlaceboEach subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months | Other | Placebo |
Primary outcome
Residual Beta-cell Function (RBCF)
Time frame: Baseline to 12 months at 3 months interval
Investigation of the effect of vitamin D on residual beta cell function (RBCF) in the first 12 months after the diagnosis of T1D by using stimulated C-peptide levels to quantify RBCF.
4 secondary outcomes
Change in Percent of HbA1c From Baseline Over Time During Partial Clinical Remission (PCR)
Time frame: Baseline to 12 months
Glucagon-like Peptide-1 (GLP-1)
Time frame: Baseline to 12 months at 3 months interval
Vitamin D Binding Protein (VDBP)
Time frame: Baseline to 12 months at 3 months interval
Effect of Vitamin D Supplementation on the Duration of Partial Clinical Remission (PCR) of Type 1 Diabetes
Time frame: Baseline to12 months 3 monthly
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No.
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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.
Benjamin U Nwosu, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ergocalciferol in people with Type 1 Diabetes, run by Benjamin U. Nwosu, MD 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 7 inclusion and 9 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 10 Jul 2024. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 10 Jul 2024). 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?
Residual Beta-cell Function (RBCF) (time frame: Baseline to 12 months at 3 months interval). 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 10 Jul 2024.