Trial Outcomes & Findings for Vitamin D Supplementation Requirement in Obese Subjects (NCT NCT00996866)

Results Overview

Vitamin D (25(OH)D) level at Baseline.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

Baseline

Results posted on

2023-07-03

Participant Flow

Volunteers were recruited during the winter months from areas in a surrounding Long Island, New York by advertisement through flyers and direct mail. Volunteers were 18-65 years old with a BMI of \>35kg/m2. Recruitment began in January of 2009 at the Bone Mineral Research Center at Winthrop University Hospital

Participants underwent a comprehensive history and physical examination and provides a blood specimen for laboratory measurements at baseline. Participants with 25(OH)D greater or equal to 80nmol/L at baseline were excluded from the study. The anticipated enrollment of 39 was an error.

Participant milestones

Participant milestones
Measure	Placebo Half of subjects will be randomized to the placebo group. placebo: The placebo group will receive sugar pills appearing similar to the vitamin D capsules.	Vitamin D3 This is the study group that receives Vitamin D supplementation. Vitamin D3: Vitamin D supplementation will follow an algorithm for initial vitamin D dosing and for dose changes. Subjects will receive 100 ug/day of vitamin D3 if their 25(OH)D level is less than 50nmol/L and 50 ug/day if their 25(OH)D level is between 50 and 80 ug/day.
Overall Study STARTED	13	14
Overall Study COMPLETED	13	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vitamin D Supplementation Requirement in Obese Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=13 Participants Half of subjects will be randomized to the placebo group. placebo: The placebo group will receive sugar pills appearing similar to the vitamin D capsules.	Vitamin D3 n=14 Participants This is the study group that receives Vitamin D supplementation. Vitamin D3: Vitamin D supplementation will follow an algorithm for initial vitamin D dosing and for dose changes. Subjects will receive 100 ug/day of vitamin D3 if their 25(OH)D level is less than 50nmol/L and 50 ug/day if their 25(OH)D level is between 50 and 80 ug/day.	Total n=27 Participants Total of all reporting groups
Age, Continuous	55.8 years STANDARD_DEVIATION 7.43 • n=39 Participants	53.5 years STANDARD_DEVIATION 12.5 • n=41 Participants	54.8 years STANDARD_DEVIATION 9.83 • n=35 Participants
Age, Customized <=18 years	0 participants n=39 Participants	0 participants n=41 Participants	0 participants n=35 Participants
Age, Customized Between 18 and 65 years	13 participants n=39 Participants	14 participants n=41 Participants	27 participants n=35 Participants
Age, Customized >=65 years	0 participants n=39 Participants	0 participants n=41 Participants	0 participants n=35 Participants
Sex/Gender, Customized Female	5 participants n=39 Participants	8 participants n=41 Participants	13 participants n=35 Participants
Sex/Gender, Customized Male	8 participants n=39 Participants	6 participants n=41 Participants	14 participants n=35 Participants
Region of Enrollment United States	13 participants n=39 Participants	14 participants n=41 Participants	27 participants n=35 Participants

PRIMARY outcome

Timeframe: Baseline

Vitamin D (25(OH)D) level at Baseline.

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants	Vitamin D n=11 Participants
Mean Level of 25(OH)D	51.1 nmol/L Standard Deviation 13.9	49.2 nmol/L Standard Deviation 15.3

PRIMARY outcome

Timeframe: Week 8

Vitamin D (25(OH)D) level at Month 2.

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants	Vitamin D n=11 Participants
Mean Level of 25(OH)D	49.9 nmol/L Standard Deviation 17.9	74.5 nmol/L Standard Deviation 13.43

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vitamin D3

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

John Aloia, MD

Winthrop-University Hospital

Phone: 516-663-2442

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place