NCT04286529

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2021

Completed
11 months until next milestone

Results Posted

Study results publicly available

April 18, 2022

Completed
Last Updated

April 18, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

February 25, 2020

Results QC Date

December 13, 2021

Last Update Submit

February 17, 2022

Conditions

Pre-Diabetic

Keywords

Pre-menopausal women

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • PROMIS 10 Questionnaire

    8 weeks

Study Arms (4)

Men-Calcitriol

ACTIVE COMPARATOR

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

Drug: Calcitriol capsules

Premenopausal Women-Calcitriol

ACTIVE COMPARATOR

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

Drug: Calcitriol capsules

Men-Placebo

PLACEBO COMPARATOR

0.25mcg capsule daily for eight weeks

Drug: Oral Placebo

Premenopausal Women-Placebo

PLACEBO COMPARATOR

0.25mcg capsule daily for eight weeks

Drug: Oral Placebo

Interventions

Calcitriol capsulesDRUG

0.25micrograms, taken daily for eight weeks, orally

Men-CalcitriolPremenopausal Women-Calcitriol
Oral PlaceboDRUG

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

Men-PlaceboPremenopausal Women-Placebo

Eligibility Criteria

Age20 Years - 45 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMenopausal status is of interest to the study.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DihydroxycholecalciferolsHydroxycholecalciferolsCholecalciferolCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Results Point of Contact

Title
Rajiv Kumar, MD
Organization
Mayo Clinic
rkumar@mayo.edu
507-284-0020

Study Officials

  • Rajiv Kumar, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2020

First Posted

February 27, 2020

Study Start

October 1, 2020

Primary Completion

May 28, 2021

Study Completion

May 28, 2021

Last Updated

April 18, 2022

Results First Posted

April 18, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)