Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes - Full Text View

Sponsor:	National Institutes of Health (NIH)
Collaborator:	Tufts Medical Center
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00436475

Purpose

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.

Condition	Intervention	Phase
Glucose Intolerance Type 2 Diabetes Mellitus Metabolic Syndrome	Drug: Vitamin D3 2,000 IU orally once daily Drug: Calcium Carbonate 400 mg orally twice daily Drug: Vitamin D3-Placebo Drug: Calcium-Placebo	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Calcium Diabetes

Drug Information available for: Cholecalciferol Calcium gluconate Calcium carbonate Vitamin D

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

Insulin sensitivity, Insulin secretion and Disposition Index [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

glucose tolerance (fasting, after OGTT), systemic inflammation, lipoprotein profile, blood pressure, body weight and body composition [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Genetic studies on Vitamin D related genes and risk of type 2 diabetes and cardiometabolic outcomes [ Time Frame: 4 months ] [ Designated as safety issue: No ]
To collect and archive biological specimens (serum, plasma, DNA) so that they can be used for testing of new hypotheses either within the parent stud or through future ancillary studies. [ Time Frame: 0 and 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	112
Study Start Date:	September 2007
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily	Drug: Vitamin D3 2,000 IU orally once daily Vitamin D3 2,000 IU orally once daily Drug: Calcium Carbonate 400 mg orally twice daily Calcium Carbonate 400 mg orally twice daily
2 Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily	Drug: Vitamin D3 2,000 IU orally once daily Vitamin D3 2,000 IU orally once daily Drug: Calcium-Placebo Calcium-Placebo
3 Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily	Drug: Calcium Carbonate 400 mg orally twice daily Calcium Carbonate 400 mg orally twice daily Drug: Vitamin D3-Placebo Vitamin D3-Placebo
4 Vitamin D3-Placebo plus Calcium-Placebo	Drug: Vitamin D3-Placebo Vitamin D3-Placebo Drug: Calcium-Placebo Calcium-Placebo

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.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436475

Contacts

Contact: Marie Francia, MD	617-636-2834	caddm@tufts-nemc.org
Contact: Anastassios Pittas, MD	617-636-2834	caddm@tufts-nemc.org

Locations

United States, Massachusetts
Tufts-New England Medical Center	Recruiting
Boston, Massachusetts, United States, 02111
Contact: Marie Francia, MD 617-636-2834 caddm@tufts-nemc.org
Contact: Noah Lubowsky, MD 617-636-2834 caddm@tufts-nemc.org
Principal Investigator: Anastassios G Pittas, MD MS
Sub-Investigator: Bess Dawson-Hughes, MD
Sub-Investigator: Frank Hu, MD PhD

Sponsors and Collaborators

National Institutes of Health (NIH)

Tufts Medical Center

Investigators

Principal Investigator:

Anastassios G Pittas, MD MS

Tufts Medical Center

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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. Epub 2007 Mar 27. Review.

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.

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.

Responsible Party:	Tufts-New England Medical Center ( Anastassios G. Pittas )
Study ID Numbers:	DK76092, DK76092
Study First Received:	February 16, 2007
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00436475 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Glucose intolerance
Type 2 diabetes mellitus
Metabolic syndrome

Additional relevant MeSH terms:

Cholecalciferol
Metabolic Diseases
Disease
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Glucose Intolerance
Ergocalciferols
Diabetes Mellitus
Endocrine System Diseases
Bone Density Conservation Agents
Calcium Carbonate

Pharmacologic Actions
Calcium, Dietary
Pathologic Processes
Hyperglycemia
Vitamin D
Vitamins
Syndrome
Diabetes Mellitus, Type 2
Antacids
Micronutrients
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009