Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

— CaDDM  

Official title:

Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436475
• Other study ID #: DK76092 (completed)
• Secondary ID: R01DK076092DK760
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2007
• Est. completion date: November 2009

Study information

• Verified date: July 2019
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Ethnicity: all ethnic groups

• Gender: men and women

• Age

1. Lower age limit: 40 years inclusive

2. Upper age limit: NONE

• BMI

1. Lower BMI limit: 25 inclusive

2. Upper BMI limit: 40 inclusive

• Glucose Intolerance / Mild Diabetes defined as

1. Fasting glucose =100 mg/dl OR

2. 2-hr glucose after OGTT =140 mg/dl OR

3. 5.8 = Hemoglobin A1c = 7

Major Exclusion Criteria:

• Diabetes requiring pharmacotherapy

• Smoking

• Hyperparathyroidism

• Hypercalcemia (Calcium > 10.5 mg/dl)

• Kidney stone

• Pregnancy

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Metabolic Syndrome
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Vitamin D3 2,000 IU orally once daily
Vitamin D3 2,000 IU orally once daily
• Calcium Carbonate 400 mg orally twice daily
Calcium Carbonate 400 mg orally twice daily
• Vitamin D3-Placebo
Vitamin D3-Placebo
• Calcium-Placebo
Calcium-Placebo

Locations

Country	Name	City	State
United States	Tufts-New England Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. Epub 2007 Feb 2. — View 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. Epub 2007 Mar 27. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chang in Disposition Index, a Measure of Beta Cell Function	Range is 0 to infinity Lower is better.	baseline and 4 months
Secondary	Change in Hemoglobin A1c	This outcome measures change in Hemoglobin A1c, a measure of glycemia	Baseline to 4 months

External Links

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