Trial Outcomes & Findings for Does Treatment of Hypovitaminosis D Increase Calcium Absorption? (NCT NCT00581828)

NCT ID: NCT00581828

Last Updated: 2023-07-24

Results Overview

percent and true fractional calcium absorption

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 19 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2023-07-24

Participant Flow

Participant milestones

Measure	Vitamin D Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
Overall Study STARTED	19
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Vitamin D Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
Overall Study Protocol Violation	1

Baseline Characteristics

Does Treatment of Hypovitaminosis D Increase Calcium Absorption?

Baseline characteristics by cohort

Measure	Vitamin D n=19 Participants Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	58 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: One subject's urine sample was mishandled, leaving 18 subjects with complete data for analysis.

percent and true fractional calcium absorption

Outcome measures

Measure	Vitamin D n=18 Participants Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
Change in Intestinal Calcium Absorption From Baseline to One Month	3 percent calcium absorption Standard Deviation 1

Adverse Events

Vitamin D

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

Dr Karen Hansen

University of Wisconsin

Phone: 608-263-3457

Email: keh@medicine.wisc.edu

Results disclosure agreements

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