Trial Outcomes & Findings for Vitamin D Supplementation on Cardiovascular Risk Factors (NCT NCT01412710)

NCT ID: NCT01412710

Last Updated: 2017-12-12

Results Overview

Total cholesterol will be used as surrogate measures for cardiovascular disease risk.

Recruitment status

COMPLETED

Study phase

Target enrollment

92 participants

Primary outcome timeframe

Baseline

Results posted on

2017-12-12

Participant Flow

Subjects were recruited from two clinics in Miami-Dade County, Florida (Borinquen Health Care Center and Clinical Care Medical Center) from July 2011 to March 2013 using flyers explaining the purpose of the study.

15 participants did not qualified due to normal levels of serum vitamin D, 25-hydroxy vitamin D \[25(OH)D\].

Participant milestones

Participant milestones
Measure	4000 IU Group This group received 4000 IU/day vitamin D3 for 6 months.	6000 IU Group This group received 6000 IU/day vitamin D3 for 6 months.
Overall Study STARTED	50	27
Overall Study COMPLETED	46	22
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vitamin D Supplementation on Cardiovascular Risk Factors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	4000 IU Group n=50 Participants This group will be given cholecalciferol 4000 IU once daily, orally for 6 months.	6000 IU Group n=27 Participants This group will be given cholecalciferol 6000 IU once daily, orally for 6 months.	Total n=77 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants	23 Participants n=7 Participants	67 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	54.76 years STANDARD_DEVIATION 8.56 • n=5 Participants	54.17 years STANDARD_DEVIATION 10.99 • n=7 Participants	54.46 years STANDARD_DEVIATION 9.77 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	15 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	40 Participants n=5 Participants	25 Participants n=7 Participants	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	50 Participants n=5 Participants	27 Participants n=7 Participants	77 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Total cholesterol baseline.

Total cholesterol will be used as surrogate measures for cardiovascular disease risk.

Outcome measures

Outcome measures
Measure	4000 IU Group n=50 Participants Vitamin D 4000 IU/day	6000 IU Group n=27 Participants Vitamin D 6000 IU/day
Blood Lipid	213.08 mg/dl Standard Deviation 42.30	193.88 mg/dl Standard Deviation 41.03

SECONDARY outcome

Timeframe: Baseline

Population: A1C baseline.

hemoglobin A1C blood test

Outcome measures

Outcome measures
Measure	4000 IU Group n=50 Participants Vitamin D 4000 IU/day	6000 IU Group n=27 Participants Vitamin D 6000 IU/day
Glycemic Control	8.25 Percentage of Hemoglobin Standard Deviation 2.40	8.26 Percentage of Hemoglobin Standard Deviation 1.92

Adverse Events

4000 IU Vitamin D3/Day

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

6000 IU Vitamin D3/Day

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

Fatma G. Huffman

Florida International University

Phone: 305-348-3877

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place