RecruitingPhase 4ACTRN12609000043235

Can Calcium and Vitamin D reduce diabetes risk in people at high risk?

Impact of vitamin D and calcium supplementation on the metabolic profile of glucose intolerant and vitamin D deficient obese subjects: a double blind, randomised and controlled trial


Sponsor

Professor Peter Ebeling

Enrollment

160 participants

Start Date

Jan 5, 2009

Study Type

Interventional

Conditions

Summary

Type 2 diabetes is Australia's fastest growing chronic disease. Simple strategies to prevent this disease at an early stage (pre-diabetes) in people at high risk are urgently needed. Recently, a lack of calcium and vitamin D has been associated with the development of diabetes. This 6-month study will determine if taking vitamin D and calcium supplements could decrease diabetes risk and cardiovascular risk factors in overweight or obese people with pre-diabetes who lack vitamin D. It will also increase our understanding of the mechanisms through which vitamin D and calcium alter diabetes and cardiovascular disease risk.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking vitamin D and calcium supplements can lower the risk of developing type 2 diabetes in people who are already at high risk. Type 2 diabetes is Australia's fastest-growing chronic disease. Researchers have noticed that low vitamin D levels may be linked to a higher chance of developing diabetes. Over 6 months, participants will take either vitamin D and calcium supplements or placebos (inactive pills) to find out if the supplements reduce diabetes risk and improve heart health. You may be eligible if: - You are 18 years or older - You are overweight or obese (BMI between 25 and 35 kg/m²) - You have been found to have pre-diabetes (impaired fasting glucose or impaired glucose tolerance) - You are deficient in vitamin D You may NOT be eligible if: - You are pregnant or breastfeeding - You have kidney disease, cirrhosis, or malabsorption problems - You have high blood calcium or a history of kidney stones - You have an active inflammatory disease - You have recently changed diabetes-related or weight medications - You have had or are planning bariatric (weight loss) surgery - Your weight has changed by more than 5% in the past 3 months Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The treatment group will receive both calcium carbonate tablets 1200 mg daily and cholecalciferol tablets 2,000 IU daily for 6 months. Cholecalciferol will be increased to 4,000 IU daily after 2 month

The treatment group will receive both calcium carbonate tablets 1200 mg daily and cholecalciferol tablets 2,000 IU daily for 6 months. Cholecalciferol will be increased to 4,000 IU daily after 2 months if the serum 25-hydroxyvitamin D levels are less than 75 nmol/L.


Locations(1)

Australia

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ACTRN12609000043235


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