Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes (CaDDM)

This study has been completed.
Sponsor:
Collaborator:
Tufts Medical Center
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00436475
First received: February 16, 2007
Last updated: March 15, 2011
Last verified: March 2011
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Disposition Index [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Insulin sensitivity, Insulin secretion, 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
Study Completion Date: November 2009
Primary Completion Date: November 2009 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
Tufts-New England Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: Anastassios G Pittas, MD MS Tufts Medical Center
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anastassios G. Pittas, Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00436475     History of Changes
Other Study ID Numbers: DK76092 (completed), DK76092
Study First Received: February 16, 2007
Last Updated: March 15, 2011
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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Intolerance
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Insulin Resistance
Hyperinsulinism
Calcium, Dietary
Cholecalciferol
Vitamin D
Ergocalciferols
Calcium Carbonate
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 26, 2014