Trial Outcomes & Findings for Safety of Vitamin D Supplementation in Older Persons (NCT NCT00681590)

NCT ID: NCT00681590

Last Updated: 2017-01-26

Results Overview

calcium serum levels measured at baseline and at the end of the intervention (6-months)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 105 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-01-26

Participant Flow

Participant milestones

Measure	Vitamin D 400 IU participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)	Vitamin D 2000 IU participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
Overall Study STARTED	34	71
Overall Study COMPLETED	32	59
Overall Study NOT COMPLETED	2	12

Reasons for withdrawal

Measure	Vitamin D 400 IU participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)	Vitamin D 2000 IU participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
Overall Study Withdrawal by Subject	2	12

Baseline Characteristics

Safety of Vitamin D Supplementation in Older Persons

Baseline characteristics by cohort

Measure	Vitamin D 400 IU n=34 Participants participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)	Vitamin D 2000 IU n=71 Participants participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)	Total n=105 Participants Total of all reporting groups
Age, Continuous	72.8 years STANDARD_DEVIATION 5.9 • n=5 Participants	73.9 years STANDARD_DEVIATION 6.7 • n=7 Participants	73.5 years STANDARD_DEVIATION 6.5 • n=5 Participants
Gender Female	28 Participants n=5 Participants	59 Participants n=7 Participants	87 Participants n=5 Participants
Gender Male	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

calcium serum levels measured at baseline and at the end of the intervention (6-months)

Outcome measures

Measure	Vitamin D 400 IU n=34 Participants participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)	Vitamin D 2000 IU n=71 Participants participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
Number of Participants Who Develop Hypercalcemia	0 participants	2 participants

SECONDARY outcome

Timeframe: baseline and 6 months

Outcome measures

Measure	Vitamin D 400 IU n=34 Participants participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)	Vitamin D 2000 IU n=71 Participants participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
Change From Baseline in Serum 25-hydroxyvitamin D Levels	-0.5 ng/ml Standard Deviation 1	6.5 ng/ml Standard Deviation 6

Adverse Events

Vitamin D 400 IU

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vitamin D 2000 IU

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Vitamin D 400 IU n=34 participants at risk participants received one tablet containing cholecalciferol 400 IU daily orally (low dose)	Vitamin D 2000 IU n=71 participants at risk participants received one tablet containing cholecalciferol 2000 IU daily orally (high dose)
Endocrine disorders hypercalcemia	0.00% 0/34 • Adverse events were collected during the 6 months of the intervention.	2.8% 2/71 • Number of events 2 • Adverse events were collected during the 6 months of the intervention.

Additional Information

Dr. Silvina Levis

University of Miami

Phone: 305-575-3388

Email: slevis@miami.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place