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

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ClinicalTrials.gov Identifier: NCT00436475
Recruitment Status : Completed
First Posted : February 19, 2007
Results First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Tufts Medical Center

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.

Condition or disease Intervention/treatment 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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D and Calcium Homeostasis for Prevention of Type 2 Diabetes
Study Start Date : September 2007
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Vitamin D

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Chang in Disposition Index, a Measure of Beta Cell Function [ Time Frame: baseline and 4 months ]
    Range is 0 to infinity Lower is better.


Secondary Outcome Measures :
  1. Change in Hemoglobin A1c [ Time Frame: Baseline to 4 months ]
    This outcome measures change in Hemoglobin A1c, a measure of glycemia



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00436475


Locations
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United States, Massachusetts
Tufts-New England Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Anastassios G Pittas, MD MS Tufts Medical Center
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00436475    
Other Study ID Numbers: DK76092 (completed)
R01DK076092 ( U.S. NIH Grant/Contract )
DK76092
First Posted: February 19, 2007    Key Record Dates
Results First Posted: July 30, 2019
Last Update Posted: July 30, 2019
Last Verified: July 2019
Keywords provided by Tufts Medical Center:
Glucose intolerance
Type 2 diabetes mellitus
Metabolic syndrome
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Metabolic Syndrome
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism
Hyperglycemia
Calcium, Dietary
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Calcium Carbonate
Calcium
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents