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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-05-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Pre-Diabetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Men-Calcitriol

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

Group Type ACTIVE_COMPARATOR

Calcitriol capsules

Intervention Type DRUG

0.25micrograms, taken daily for eight weeks, orally

Premenopausal Women-Calcitriol

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

Group Type ACTIVE_COMPARATOR

Calcitriol capsules

Intervention Type DRUG

0.25micrograms, taken daily for eight weeks, orally

Men-Placebo

0.25mcg capsule daily for eight weeks

Group Type PLACEBO_COMPARATOR

Oral Placebo

Intervention Type DRUG

Placebo will be created to mimic the appearance of the study drug

Premenopausal Women-Placebo

0.25mcg capsule daily for eight weeks

Group Type PLACEBO_COMPARATOR

Oral Placebo

Intervention Type DRUG

Placebo will be created to mimic the appearance of the study drug

Interventions

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Calcitriol capsules

0.25micrograms, taken daily for eight weeks, orally

Intervention Type DRUG

Oral Placebo

Placebo will be created to mimic the appearance of the study drug

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes