Trial Outcomes & Findings for Vitamin D Dose Finding Study (NCT NCT01092338)

Last Updated: 2013-09-18

Results Overview

Determined by incidence of elevated serum calcium (above age specific range) associated with elevated serum 25D concentrations (\>160ng/ml).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

12 weeks

Results posted on

2013-09-18

Participant Flow

The Study started enrollment in 01/2010 and completed in 01/2011. A total of 44 subjects were enrolled including 19 with perinatally-acquired HIV/AIDS (PA) and 25 with behaviorally-acquired HIV/AIDS (BA).

Subjects taking a vitamin D supplement or multi-vitamin were eligible if they were willing to discontinue supplementation after a minimum of a 2 month washout period.

Participant milestones

Participant milestones
Measure	4000IU/d of Vitamin D3	7000IU/d Vitamin D3
Overall Study STARTED	22	22
Overall Study COMPLETED	21	21
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vitamin D Dose Finding Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	4000IU/d of Vitamin D3 n=22 Participants	7000IU/d Vitamin D3 n=22 Participants	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	18.4 years STANDARD_DEVIATION 4.5 • n=5 Participants	19.1 years STANDARD_DEVIATION 5.0 • n=7 Participants	18.7 years STANDARD_DEVIATION 4.7 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	22 participants n=7 Participants	44 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Number of subjects with elevated serum calcium (above age specific range) associated with elevated serum 25D concentrations (\>160ng/ml)

Determined by incidence of elevated serum calcium (above age specific range) associated with elevated serum 25D concentrations (\>160ng/ml).

Outcome measures

Outcome measures
Measure	4000IU/d of Vitamin D3 n=22 Participants	7000IU/d Vitamin D3 n=22 Participants
Safety	0 participants	0 participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Number of subjects with serum 25D concentration levels \>= 32 ng/ml after 12 weeks of supplementation.

Daily D3 supplementation will result in 25D \>= to 32/ng/ml

Outcome measures

Outcome measures
Measure	4000IU/d of Vitamin D3 n=22 Participants	7000IU/d Vitamin D3 n=22 Participants
Efficacy of the Two Doses (4000 and 7000 IU/d)	16 participants	19 participants

Adverse Events

4000IU/d of Vitamin D3

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

7000IU/d Vitamin D3

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	4000IU/d of Vitamin D3 n=22 participants at risk	7000IU/d Vitamin D3 n=22 participants at risk
Gastrointestinal disorders nausea	13.6% 3/22 • Number of events 3	18.2% 4/22 • Number of events 5
General disorders General	18.2% 4/22 • Number of events 5	18.2% 4/22 • Number of events 4
Skin and subcutaneous tissue disorders Rash	4.5% 1/22 • Number of events 1	9.1% 2/22 • Number of events 2
Infections and infestations Infection	18.2% 4/22 • Number of events 4	4.5% 1/22 • Number of events 2
Musculoskeletal and connective tissue disorders Pain	9.1% 2/22 • Number of events 2	9.1% 2/22 • Number of events 2
Respiratory, thoracic and mediastinal disorders Asthma	4.5% 1/22 • Number of events 1	0.00% 0/22
Injury, poisoning and procedural complications Injury	4.5% 1/22 • Number of events 1	9.1% 2/22 • Number of events 2
Respiratory, thoracic and mediastinal disorders Cough/Cold	9.1% 2/22 • Number of events 3	0.00% 0/22

Additional Information

Virginia Stallings

Children's Hospital of Philadephia

Phone: 215-590-1664

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place