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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000043235

Enrollment

160

Registered

2009-01-20

Start date

2009-01-05

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 months if the serum 25-hydroxyvitamin D levels are less than 75 nmol/L.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Vitamin D deficiency; overweight or obese as defined by a body-mass index (BMI) between 25-35 kg/m2; impaired fasting glucose or impaired glucose tolerance confirmed with a 75g 2h oral glucose tolerance test (OGTT).

Exclusion criteria

Pregnancy; Breast-feeding; Renal insufficiency; Cirrhosis; Malabsorption; Hypercalcemia; Hypercalciuria; History of nephrolithiasis; Previous non-traumatic fractures; Active or chronic inflammatory disease;Medications known to affect vitamin D, calcium or bone metabolism over the last 3 months; Pharmacological treatment for obesity or medications known to alter glucose metabolism over the last 3 months; Bariatric surgery planned in the next six months or patients who had undergone bariatric surgery in the past; Commenced regular physical activity (more than 3 times/week) in the last 3 months; More than a 5% change in weight in the last 3 months.

Outcome results