Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes (CaDDM)
Primary Purpose
Glucose Intolerance, Type 2 Diabetes Mellitus, Metabolic Syndrome
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3 2,000 IU orally once daily
Calcium Carbonate 400 mg orally twice daily
Vitamin D3-Placebo
Calcium-Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Glucose Intolerance focused on measuring Glucose intolerance, Type 2 diabetes mellitus, Metabolic syndrome
Eligibility Criteria
Inclusion Criteria:
- Ethnicity: all ethnic groups
- Gender: men and women
Age
- Lower age limit: 40 years inclusive
- Upper age limit: NONE
BMI
- 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
Sites / Locations
- Tufts-New England Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
1
2
3
4
Arm Description
Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily
Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily
Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily
Vitamin D3-Placebo plus Calcium-Placebo
Outcomes
Primary Outcome Measures
Chang in Disposition Index, a Measure of Beta Cell Function
Range is 0 to infinity Lower is better.
Secondary Outcome Measures
Change in Hemoglobin A1c
This outcome measures change in Hemoglobin A1c, a measure of glycemia
Full Information
NCT ID
NCT00436475
First Posted
February 16, 2007
Last Updated
July 8, 2019
Sponsor
Tufts Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00436475
Brief Title
Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes
Acronym
CaDDM
Official Title
Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Intolerance, Type 2 Diabetes Mellitus, Metabolic Syndrome
Keywords
Glucose intolerance, Type 2 diabetes mellitus, Metabolic syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily
Arm Title
2
Arm Type
Other
Arm Description
Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily
Arm Title
3
Arm Type
Other
Arm Description
Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily
Arm Title
4
Arm Type
Other
Arm Description
Vitamin D3-Placebo plus Calcium-Placebo
Intervention Type
Drug
Intervention Name(s)
Vitamin D3 2,000 IU orally once daily
Intervention Description
Vitamin D3 2,000 IU orally once daily
Intervention Type
Drug
Intervention Name(s)
Calcium Carbonate 400 mg orally twice daily
Intervention Description
Calcium Carbonate 400 mg orally twice daily
Intervention Type
Drug
Intervention Name(s)
Vitamin D3-Placebo
Intervention Description
Vitamin D3-Placebo
Intervention Type
Drug
Intervention Name(s)
Calcium-Placebo
Intervention Description
Calcium-Placebo
Primary Outcome Measure Information:
Title
Chang in Disposition Index, a Measure of Beta Cell Function
Description
Range is 0 to infinity Lower is better.
Time Frame
baseline and 4 months
Secondary Outcome Measure Information:
Title
Change in Hemoglobin A1c
Description
This outcome measures change in Hemoglobin A1c, a measure of glycemia
Time Frame
Baseline to 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ethnicity: all ethnic groups
Gender: men and women
Age
Lower age limit: 40 years inclusive
Upper age limit: NONE
BMI
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anastassios G Pittas, MD MS
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts-New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17389701
Citation
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.
Results Reference
background
PubMed Identifier
17277040
Citation
Pittas 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.
Results Reference
background
PubMed Identifier
16505521
Citation
Pittas 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.
Results Reference
background
PubMed Identifier
28945992
Citation
Nunez 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.
Results Reference
derived
PubMed Identifier
27194308
Citation
Alzaman 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.
Results Reference
derived
PubMed Identifier
21715514
Citation
Mitri 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.
Results Reference
derived
Links:
URL
http://www.caddm.org
Description
Related Info
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Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes
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