Trial Outcomes & Findings for Effect of Vitamin D3 Supplementation on Insulin Resistance- The DIR Study (NCT NCT01889810)

NCT ID: NCT01889810

Last Updated: 2023-05-06

Results Overview

Insulin resistance will be measured using the gold standard euglycaemic-hyperinsulinaemic clamp method (note - it is anticipated that a total of 60 volunteers will complete the primary endpoint assessment).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

81 participants

Primary outcome timeframe

Measured at baseline and after 6 months

Results posted on

2023-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Vitamin D3 Supplementation Patients will take 3000IU (75 µg) Vitamin D3 supplementation per day for a period of 26 weeks. Vitamin D3 supplementation: 3000IU (75µg) vitamin D3 will be given daily for a period of 26 weeks to the group who receive the active comparator. The efficacy of vitamin D3 supplementation on insulin resistance will be compared to the placebo group.	Placebo Placebo group Vitamin D3 supplementation: 3000IU (75µg) vitamin D3 will be given daily for a period of 26 weeks to the group who receive the active comparator. The efficacy of vitamin D3 supplementation on insulin resistance will be compared to the placebo group.
Overall Study STARTED	35	31
Overall Study COMPLETED	34	30
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin D3 Supplementation n=35 Participants Patients will take 3000IU (75 µg) Vitamin D3 supplementation per day for a period of 26 weeks. Vitamin D3 supplementation: 3000IU (75µg) vitamin D3 will be given daily for a period of 26 weeks to the group who receive the active comparator. The efficacy of vitamin D3 supplementation on insulin resistance will be compared to the placebo group.	Placebo n=31 Participants Placebo group Vitamin D3 supplementation: 3000IU (75µg) vitamin D3 will be given daily for a period of 26 weeks to the group who receive the active comparator. The efficacy of vitamin D3 supplementation on insulin resistance will be compared to the placebo group.	Total n=66 Participants Total of all reporting groups
Age, Continuous	52.4 years STANDARD_DEVIATION 2.0 • n=35 Participants	54.0 years STANDARD_DEVIATION 1.7 • n=31 Participants	53.3 years STANDARD_DEVIATION 2.02 • n=66 Participants
Sex: Female, Male Female	16 Participants n=35 Participants	11 Participants n=31 Participants	27 Participants n=66 Participants
Sex: Female, Male Male	19 Participants n=35 Participants	20 Participants n=31 Participants	39 Participants n=66 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Measured at baseline and after 6 months

Insulin resistance will be measured using the gold standard euglycaemic-hyperinsulinaemic clamp method (note - it is anticipated that a total of 60 volunteers will complete the primary endpoint assessment).

Outcome measures

Outcome measures
Measure	Vitamin D3 Supplementation n=33 Participants Patients will take 3000IU (75 µg) Vitamin D3 supplementation per day for a period of 26 weeks. Vitamin D3 supplementation: 3000IU (75µg) vitamin D3 will be given daily for a period of 26 weeks to the group who receive the active comparator. The efficacy of vitamin D3 supplementation on insulin resistance will be compared to the placebo group.	Placebo n=29 Participants Placebo group Vitamin D3 supplementation: 3000IU (75µg) vitamin D3 will be given daily for a period of 26 weeks to the group who receive the active comparator. The efficacy of vitamin D3 supplementation on insulin resistance will be compared to the placebo group.
Change in Insulin Resistance	37.4 μmol/kg/min (Step 2 GIR corrected) Standard Deviation 13.8	36.3 μmol/kg/min (Step 2 GIR corrected) Standard Deviation 10.4

SECONDARY outcome

Timeframe: Measured at baseline and after 6 months

Change in vitamin D status will be measured using the gold standard Ultra performance liquid chromatography followed by tandem mass spectrometry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at baseline and after 6 months

Measurements of seated and 24-hour ambulatory blood pressure, lipids, homeostasis model assessment (HOMA), HbA1c, and inflammatory and immune function markers including tumour necrosis factor-alpha and high sensitivity c-reactive protein

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at baseline and after 6 months

Assessed by sequential tonometry with ECG gating using the SphygmoCor PWV System

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at baseline and after 6 months

Assessed using hand held dynamometer

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at baseline and after 6 months

SF-36 Questionnaire

Outcome measures

Outcome data not reported

Adverse Events

Vitamin D3 Supplementation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Adverse event data not reported

Additional Information

Professor Michelle McKinley

Queen's University, Belfast

Phone: 02890978936

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place