Trial Outcomes & Findings for Effect of 1,25-dihydroxyvitamin D3, Treatment on Insulin Secretion and Muscle Strength in Pre-diabetic Persons (NCT NCT04286529)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

17 participants

Primary outcome timeframe

Baseline and 8 weeks

Results posted on

2022-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	Men-Calcitriol Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally	Premenopausal Women-Calcitriol Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally	Men-Placebo 0.25mcg capsule daily for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug	Premenopausal Women-Placebo 0.25mcg capsule daily for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug
Overall Study STARTED	4	4	5	4
Overall Study COMPLETED	3	1	3	1
Overall Study NOT COMPLETED	1	3	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Men-Calcitriol n=4 Participants Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally	Premenopausal Women-Calcitriol n=4 Participants Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally	Men-Placebo n=5 Participants 0.25mcg capsule daily for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug	Premenopausal Women-Placebo n=4 Participants 0.25mcg capsule daily for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug	Total n=17 Participants Total of all reporting groups
Age, Continuous	32 years STANDARD_DEVIATION 4.2 • n=5 Participants	29 years STANDARD_DEVIATION 5.2 • n=7 Participants	30 years STANDARD_DEVIATION 2.6 • n=5 Participants	27 years STANDARD_DEVIATION 2.6 • n=4 Participants	30 years STANDARD_DEVIATION 3.7 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	0 Participants n=4 Participants	9 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	14 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants	4 participants n=4 Participants	17 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Population: Data not collected or analyzed at 8 weeks for the one participant in the Premenopausal Women-Placebo study arm.

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.

Outcome measures

Outcome measures
Measure	Men-Calcitriol n=3 Participants Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally	Premenopausal Women-Calcitriol n=1 Participants Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally	Men-Placebo n=3 Participants 0.25mcg capsule daily for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug	Premenopausal Women-Placebo n=1 Participants 0.25mcg capsule daily for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug
Glucose Levels Baseline	90 mg/dL Standard Deviation 4.1	76 mg/dL Standard Deviation 0	89 mg/dL Standard Deviation 4	82 mg/dL Standard Deviation 0
Glucose Levels 8 weeks	98 mg/dL Standard Deviation 9.2	85 mg/dL Standard Deviation 0	85 mg/dL Standard Deviation 4.7	—

PRIMARY outcome

Timeframe: Baseline and 8 weeks

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.

Outcome measures

Outcome measures
Measure	Men-Calcitriol n=3 Participants Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally	Premenopausal Women-Calcitriol n=1 Participants Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally	Men-Placebo n=3 Participants 0.25mcg capsule daily for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug	Premenopausal Women-Placebo n=1 Participants 0.25mcg capsule daily for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug
Insulin Level Baseline	4.7 uIU/mL Standard Deviation 1.8	4.6 uIU/mL Standard Deviation 0	3 uIU/mL Standard Deviation 1.6	2.4 uIU/mL Standard Deviation 0
Insulin Level 8 Weeks	5 uIU/mL Standard Deviation 1.8	4 uIU/mL Standard Deviation 0	3 uIU/mL Standard Deviation 0.8	4 uIU/mL Standard Deviation 0

PRIMARY outcome

Timeframe: Baseline and 8 weeks

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.

Outcome measures

Outcome measures
Measure	Men-Calcitriol n=3 Participants Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally	Premenopausal Women-Calcitriol n=1 Participants Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally	Men-Placebo n=3 Participants 0.25mcg capsule daily for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug	Premenopausal Women-Placebo n=1 Participants 0.25mcg capsule daily for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug
C-Peptide Level Baseline	0.6 nmol/L Standard Deviation 0.07	0.5 nmol/L Standard Deviation 0	0.7 nmol/L Standard Deviation 0.3	0.5 nmol/L Standard Deviation 0
C-Peptide Level 8 Weeks	0.74 nmol/L Standard Deviation 0.07	0.55 nmol/L Standard Deviation 0	0.49 nmol/L Standard Deviation 0.08	0.52 nmol/L Standard Deviation 0

SECONDARY outcome

Timeframe: 8 weeks

Population: Data not collected or analyzed

Brief 10 question multiple choice survey

Outcome measures

Outcome data not reported

Adverse Events

Men-Calcitriol

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Premenopausal Women-Calcitriol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Men-Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Premenopausal Women-Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Men-Calcitriol n=4 participants at risk Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally	Premenopausal Women-Calcitriol n=4 participants at risk Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally	Men-Placebo n=5 participants at risk 0.25mcg capsule daily for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug	Premenopausal Women-Placebo n=4 participants at risk 0.25mcg capsule daily for eight weeks Oral Placebo: Placebo will be created to mimic the appearance of the study drug
Musculoskeletal and connective tissue disorders Deep ache medial and lateral parapatellar region	25.0% 1/4 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 9 weeks on all participants.	0.00% 0/4 • Adverse events were collected from baseline to end of study for a total of approximately 9 weeks on all participants.	0.00% 0/5 • Adverse events were collected from baseline to end of study for a total of approximately 9 weeks on all participants.	0.00% 0/4 • Adverse events were collected from baseline to end of study for a total of approximately 9 weeks on all participants.

Additional Information

Rajiv Kumar, MD

Mayo Clinic

Phone: 507-284-0020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place