Glucose IntolerancePhase 1/2CaDDMNCT00436475
Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes
A Phase 1/2 study testing Vitamin D3 2,000 IU orally once daily and Calcium Carbonate 400 mg orally twice daily in people with Glucose Intolerance and Type 2 Diabetes Mellitus, run by Tufts Medical Center at 1 site in United States.
Trial summary
The purpose of the randomized trial is to quantify the effect of vitamin D and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for type 2 diabetes. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glucose Intolerance, Type 2 Diabetes Mellitus, Metabolic Syndrome
- What is being tested?
- Vitamin D3 2,000 IU orally once daily and Calcium Carbonate 400 mg orally twice daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Nov 2009
- Phase
- Phase 1/2
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ethnicity: all ethnic groups
- Gender: men and women
- Age
- Lower age limit: 40 years inclusive
- Upper age limit: NONE
- BMI
Show all 19Show fewer
- Lower BMI limit: 25 inclusive
- Upper BMI limit: 40 inclusive
- Glucose Intolerance / Mild Diabetes defined as
- Fasting glucose ≥100 mg/dl OR
- 2-hr glucose after OGTT ≥140 mg/dl OR
- 5.8 ≤ Hemoglobin A1c ≤ 7
- Major Exclusion Criteria:
- Diabetes requiring pharmacotherapy
- Smoking
- Hyperparathyroidism
- Hypercalcemia (Calcium > 10.5 mg/dl)
- Kidney stone
- Pregnancy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts-New England Medical Center
Boston, Massachusetts, 02111
About this study
The purpose of the randomized trial is to quantify the effect of vitamin D and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for type 2 diabetes.
Read the detailed description
There is animal and human observational evidence to suggest that vitamin D and calcium are important in modifying t2DM risk but there are critical gaps in our knowledge about the clinical magnitude of the association with t2DM and potential mechanisms in humans. We are conducting a randomized trial to quantify the effect of vitamin D and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for t2DM. We anticipate that the research proposed in this application is significant because it will provide the basis for defining feasible nutritional interventions that promotes prevention of t2DM. Based on the results of the proposed studies and future work in this area, vitamin D and calcium supplementation can assume an important role in the treatment of t2DM and in the prevention of the disease in the 41 million Americans who are at risk of developing t2DM.
- Being tested
- Vitamin D3 2,000 IU orally once daily, Calcium Carbonate 400 mg orally twice daily, Vitamin D3-Placebo, Calcium-Placebo
- Keywords
- Glucose intolerance, Type 2 diabetes mellitus, Metabolic syndrome
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus, Type 2, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 2,000 IU orally once dailyDrug
Vitamin D3 2,000 IU orally once daily
Calcium Carbonate 400 mg orally twice dailyDrug
Calcium Carbonate 400 mg orally twice daily
Vitamin D3-PlaceboDrug
Vitamin D3-Placebo
Calcium-PlaceboDrug
Calcium-Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily Receives: Drug: Vitamin D3 2,000 IU orally once daily; Drug: Calcium Carbonate 400 mg orally twice daily |
| 2 | Other | Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily Receives: Drug: Vitamin D3 2,000 IU orally once daily; Drug: Calcium-Placebo |
| 3 | Other | Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily Receives: Drug: Calcium Carbonate 400 mg orally twice daily; Drug: Vitamin D3-Placebo |
| 4 | Other | Vitamin D3-Placebo plus Calcium-Placebo Receives: Drug: Vitamin D3-Placebo; Drug: Calcium-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chang in Disposition Index, a Measure of Beta Cell Function
Range is 0 to infinity Lower is better.
Measured: baseline and 4 months
Secondary outcomes (1)
Change in Hemoglobin A1c
This outcome measures change in Hemoglobin A1c, a measure of glycemia
Measured: Baseline to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startSep 2007
- Primary completionNov 2009
- Study completionNov 2009
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.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Glucose IntoleranceStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anastassios G Pittas, MD MS, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436475
- Sponsor's protocol ID
- DK76092 (completed)
- Other IDs
- R01DK076092, DK76092
- Acronym
- CaDDM
- Status last verified
- Jul 2019
- First submitted
- 16 Feb 2007
- Last updated
- 30 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pittas AG, Lau J, Hu FB, Dawson-Hughes B. The role of vitamin D and calcium in type 2 diabetes. A systematic review and meta-analysis. J Clin Endocrinol Metab. 2007 Jun;92(6):2017-29. doi: 10.1210/jc.2007-0298. Epub 2007 Mar 27.
PubMed 17389701Pittas AG, Harris SS, Stark PC, Dawson-Hughes B. The effects of calcium and vitamin D supplementation on blood glucose and markers of inflammation in nondiabetic adults. Diabetes Care. 2007 Apr;30(4):980-6. doi: 10.2337/dc06-1994. Epub 2007 Feb 2.
PubMed 17277040Pittas AG, Dawson-Hughes B, Li T, Van Dam RM, Willett WC, Manson JE, Hu FB. Vitamin D and calcium intake in relation to type 2 diabetes in women. Diabetes Care. 2006 Mar;29(3):650-6. doi: 10.2337/diacare.29.03.06.dc05-1961.
PubMed 16505521Nunez Lopez YO, Pittas AG, Pratley RE, Seyhan AA. Circulating levels of miR-7, miR-152 and miR-192 respond to vitamin D supplementation in adults with prediabetes and correlate with improvements in glycemic control. J Nutr Biochem. 2017 Nov;49:117-122. doi: 10.1016/j.jnutbio.2017.08.007. Epub 2017 Aug 26.
PubMed 28945992Alzaman NS, Dawson-Hughes B, Nelson J, D'Alessio D, Pittas AG. Vitamin D status of black and white Americans and changes in vitamin D metabolites after varied doses of vitamin D supplementation. Am J Clin Nutr. 2016 Jul;104(1):205-14. doi: 10.3945/ajcn.115.129478. Epub 2016 May 18.
PubMed 27194308Mitri J, Dawson-Hughes B, Hu FB, Pittas AG. Effects of vitamin D and calcium supplementation on pancreatic beta cell function, insulin sensitivity, and glycemia in adults at high risk of diabetes: the Calcium and Vitamin D for Diabetes Mellitus (CaDDM) randomized controlled trial. Am J Clin Nutr. 2011 Aug;94(2):486-94. doi: 10.3945/ajcn.111.011684. Epub 2011 Jun 29.
PubMed 21715514
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00436475
- Acronym / sponsor ID
- CaDDM / DK76092 (completed)
- Keywords
- Glucose intolerance, Type 2 diabetes mellitus, Metabolic syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 19 Feb 2007 (estimated)
- Results
- Posted 30 Jul 2019
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 the randomized trial is to quantify the effect of vitamin D and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for type 2 diabetes.
Detailed description
There is animal and human observational evidence to suggest that vitamin D and calcium are important in modifying t2DM risk but there are critical gaps in our knowledge about the clinical magnitude of the association with t2DM and potential mechanisms in humans. We are conducting a randomized trial to quantify the effect of vitamin D and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for t2DM. We anticipate that the research proposed in this application is significant because it will provide the basis for defining feasible nutritional interventions that promotes prevention of t2DM. Based on the results of the proposed studies and future work in this area, vitamin D and calcium supplementation can assume an important role in the treatment of t2DM and in the prevention of the disease in the 41 million Americans who are at risk of developing t2DM.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Vitamin D3 2,000 IU orally once daily, Drug: Calcium Carbonate 400 mg orally twice dailyVitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily |
| 2 | Other | Drug: Vitamin D3 2,000 IU orally once daily, Drug: Calcium-PlaceboVitamin D3 2,000 IU daily plus Calcium-Placebo twice daily |
| 3 | Other | Drug: Calcium Carbonate 400 mg orally twice daily, Drug: Vitamin D3-PlaceboVitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily |
| 4 | Other | Drug: Vitamin D3-Placebo, Drug: Calcium-PlaceboVitamin D3-Placebo plus Calcium-Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Ethnicity: all ethnic groups
- Gender: men and women
- Age
- BMI
- Glucose Intolerance / Mild Diabetes defined as
Key exclusion criteria (0 listed)
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 D3 2,000 IU orally once dailyVitamin D3 2,000 IU orally once daily | Drug | 1, 2 |
| Calcium Carbonate 400 mg orally twice dailyCalcium Carbonate 400 mg orally twice daily | Drug | 1, 3 |
| Vitamin D3-PlaceboVitamin D3-Placebo | Drug | 3, 4 |
| Calcium-PlaceboCalcium-Placebo | Drug | 2, 4 |
Primary outcome
Chang in Disposition Index, a Measure of Beta Cell Function
Time frame: baseline and 4 months
Range is 0 to infinity Lower is better.
1 secondary outcome
Change in Hemoglobin A1c
Time frame: Baseline to 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17389701Pittas AG, Lau J, Hu FB, Dawson-Hughes B. The role of vitamin D and calcium in type 2 diabetes. A systematic review and meta-analysis. J Clin Endocrinol Metab. 2007 Jun;92(6):2017-29. doi: 10.1210/jc.2007-0298. Epub 2007 Mar 27.
- Background: PubMed 17277040Pittas AG, Harris SS, Stark PC, Dawson-Hughes B. The effects of calcium and vitamin D supplementation on blood glucose and markers of inflammation in nondiabetic adults. Diabetes Care. 2007 Apr;30(4):980-6. doi: 10.2337/dc06-1994. Epub 2007 Feb 2.
- Background: PubMed 16505521Pittas AG, Dawson-Hughes B, Li T, Van Dam RM, Willett WC, Manson JE, Hu FB. Vitamin D and calcium intake in relation to type 2 diabetes in women. Diabetes Care. 2006 Mar;29(3):650-6. doi: 10.2337/diacare.29.03.06.dc05-1961.
- Derived from this study: PubMed 28945992Nunez Lopez YO, Pittas AG, Pratley RE, Seyhan AA. Circulating levels of miR-7, miR-152 and miR-192 respond to vitamin D supplementation in adults with prediabetes and correlate with improvements in glycemic control. J Nutr Biochem. 2017 Nov;49:117-122. doi: 10.1016/j.jnutbio.2017.08.007. Epub 2017 Aug 26.
- Derived from this study: PubMed 27194308Alzaman NS, Dawson-Hughes B, Nelson J, D'Alessio D, Pittas AG. Vitamin D status of black and white Americans and changes in vitamin D metabolites after varied doses of vitamin D supplementation. Am J Clin Nutr. 2016 Jul;104(1):205-14. doi: 10.3945/ajcn.115.129478. Epub 2016 May 18.
- Derived from this study: PubMed 21715514Mitri J, Dawson-Hughes B, Hu FB, Pittas AG. Effects of vitamin D and calcium supplementation on pancreatic beta cell function, insulin sensitivity, and glycemia in adults at high risk of diabetes: the Calcium and Vitamin D for Diabetes Mellitus (CaDDM) randomized controlled trial. Am J Clin Nutr. 2011 Aug;94(2):486-94. doi: 10.3945/ajcn.111.011684. Epub 2011 Jun 29.
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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.
Anastassios G Pittas, MD MS principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vitamin D3 2,000 IU orally once daily and Calcium Carbonate 400 mg orally twice daily in people with Glucose Intolerance and Type 2 Diabetes Mellitus, run by Tufts Medical Center 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 19 inclusion and 0 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 30 Jul 2019. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 30 Jul 2019). 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?
Chang in Disposition Index, a Measure of Beta Cell Function (time frame: baseline and 4 months). 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 NCT00436475, which also lists 6 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 30 Jul 2019.