Effect of 1,25-dihydroxyvitamin D3, Treatment on Insulin Secretion and Muscle Strength in Pre-diabetic Persons

Mayo Clinic

Status and phase: Terminated; Phase 1

Conditions: Pre-Diabetic

Treatments: Drug: Oral Placebo; Drug: Calcitriol capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT04286529

19-010890

Details and patient eligibility

About

The purpose of this research is to study the effects of 1,25(OH)2 D3 (a prescription form of active Vitamin D) on muscle strength and insulin secretion by the pancreas and glucose utilization by skeletal muscle.

Enrollment: 17 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) of >24kg/m2
• Fasting serum glucose <126 mg/dL

Exclusion criteria

• BMI</=24 kg/m2
• Fasting serum glucose >/=126 mg/dL
• Patient is taking Calcium or Vitamin D supplements and is unwilling to stop for 8 weeks
• Serum Calcium >10.2 mg/dL
• Serum inorganic phosphorous >4.5mg/dL
• Pregnancy or breastfeeding
• Diagnosis of Diabetes Mellitus
• Diagnosis of Rheumatoid Arthritis
• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
• Renal in sufficiency/failure ( serum creatinine >1.5 mg/dL men, > 1.3 mg/dL women)
• Chronic active liver disease (bilirubin >1.2 mg/dL, AST>144IU/L, or ALT >165 IU/L)
• History of chronic hepatitis
• Active coronary artery disease ( unstable angina, myocardial infarction, stroke and revascularization of coronary, peripheral or carotid artery within the last 3 months)
• Oral warfarin group medications or history of blood clotting disorders
• Platelet count <100,000 per uL within the last 7 days
• Alcohol consumption greater than 2 glasses/day or other substance abuse
• Untreated or uncontrolled thyroid disorders (outside a TSH range of 0.5 to 10mIU/L)
• Debilitating chronic disease (at the discretion of the investigators)
• The presence of infections, highly communicable diseases ( AIDS, active tuberculosis, venereal disease, hepatitis)
• Any malignancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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17 participants in 4 patient groups, including a placebo group

Men-Calcitriol

Active Comparator group

Description:

Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.

Treatment:

Drug: Calcitriol capsules

Premenopausal Women-Calcitriol

Active Comparator group

Description:

Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.

Treatment:

Drug: Calcitriol capsules

Men-Placebo

Placebo Comparator group

Description:

0.25mcg capsule daily for eight weeks

Treatment:

Drug: Oral Placebo

Premenopausal Women-Placebo

Placebo Comparator group

Description:

0.25mcg capsule daily for eight weeks

Treatment:

Drug: Oral Placebo