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

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.

Study Overview

• Status: Terminated
• Conditions: Pre-Diabetic
• Intervention / Treatment: Drug: Oral Placebo; Drug: Calcitriol capsules

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Men-Calcitriol; Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.	Drug: Calcitriol capsules; 0.25micrograms, taken daily for eight weeks, orally
ACTIVE_COMPARATOR: Premenopausal Women-Calcitriol; Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.	Drug: Calcitriol capsules; 0.25micrograms, taken daily for eight weeks, orally
PLACEBO_COMPARATOR: Men-Placebo; 0.25mcg capsule daily for eight weeks	Drug: Oral Placebo; Placebo will be created to mimic the appearance of the study drug
PLACEBO_COMPARATOR: Premenopausal Women-Placebo; 0.25mcg capsule daily for eight weeks	Drug: Oral Placebo; Placebo will be created to mimic the appearance of the study drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose Levels	Blood will be obtained to measure glucose after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period.	Baseline and 8 weeks
Insulin Level	Blood will be obtained to measure insulin level after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period.	Baseline and 8 weeks
C-Peptide Level	Blood will be obtained to measure c-peptide level after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period.	Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS 10 Questionnaire	Brief 10 question multiple choice survey	8 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2020
• Primary Completion (ACTUAL): May 28, 2021
• Study Completion (ACTUAL): May 28, 2021

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (ACTUAL): February 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Pre-menopausal women
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Micronutrients; Membrane Transport Modulators; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Calcitriol
• Other Study ID Numbers: 19-010890

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes