Trial Outcomes & Findings for Defining Vitamin D Insufficiency in School Age Children: A Randomized Placebo Controlled Trial of Vitamin D3 (NCT NCT00732758)

Last Updated: 2015-12-29

Results Overview

Circulating concentration of 25 hydroxyvitamin D is a biomarker of vitamin D status. Vitamin D deficiency was defined as serum 25-hydroxyvitamin D concentrations \<20 ng/mL.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

157 participants

Primary outcome timeframe

6 months

Results posted on

2015-12-29

Participant Flow

We enrolled healthy 8- to 14-year-old children from October through March of 2008 through 2011.

Children receiving vitamin preparations underwent a 1-month washout before enrollment. Of 355 children assessed for eligibility, 304 were deemed eligible and among these 157 agreed to participate.

Participant milestones

Participant milestones
Measure	Vitamin D3 Group Vitamin D3 1000 IU Tablet Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months	Placebo Group Placebo Tablet Placebo Tablet: Placebo Tablet once daily for 6 months
Overall Study STARTED	78	79
Overall Study COMPLETED	70	63
Overall Study NOT COMPLETED	8	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Vitamin D3 Group Vitamin D3 1000 IU Tablet Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months	Placebo Group Placebo Tablet Placebo Tablet: Placebo Tablet once daily for 6 months
Overall Study Lost to Follow-up	8	16

Baseline Characteristics

Defining Vitamin D Insufficiency in School Age Children: A Randomized Placebo Controlled Trial of Vitamin D3

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin D3 Group n=78 Participants Vitamin D3 1000 IU Tablet Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months	Placebo Group n=79 Participants Placebo Tablet Placebo Tablet: Placebo Tablet once daily for 6 months	Total n=157 Participants Total of all reporting groups
Age, Continuous	11.2 years STANDARD_DEVIATION 1.9 • n=5 Participants	11.4 years STANDARD_DEVIATION 2.0 • n=7 Participants	11.3 years STANDARD_DEVIATION 1.95 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	34 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	45 Participants n=7 Participants	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	68 Participants n=5 Participants	63 Participants n=7 Participants	131 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	15 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	42 Participants n=5 Participants	42 Participants n=7 Participants	84 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	37 Participants n=7 Participants	73 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (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	78 participants n=5 Participants	79 participants n=7 Participants	157 participants n=5 Participants
Body Mass Index	21.6 kilograms/meters^2 STANDARD_DEVIATION 5.5 • n=5 Participants	21.6 kilograms/meters^2 STANDARD_DEVIATION 6.2 • n=7 Participants	21.6 kilograms/meters^2 STANDARD_DEVIATION 5.85 • n=5 Participants
Skin Type I (easy burn, no tan)	4 participants n=5 Participants	6 participants n=7 Participants	10 participants n=5 Participants
Skin Type II (easy burn, slight tan)	14 participants n=5 Participants	13 participants n=7 Participants	27 participants n=5 Participants
Skin Type III (burn, then tan)	15 participants n=5 Participants	16 participants n=7 Participants	31 participants n=5 Participants
Skin Type IV (no burn, good tan)	36 participants n=5 Participants	27 participants n=7 Participants	63 participants n=5 Participants
Skin Type V (never burn, marked tan)	7 participants n=5 Participants	16 participants n=7 Participants	23 participants n=5 Participants
Skin Type Unknown	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Vitamin D-deficient: Defined as serum 25(OH)D <20 ng/mL 25(OH)D<20 ng/mL	42 participants n=5 Participants	45 participants n=7 Participants	87 participants n=5 Participants
Vitamin D-deficient: Defined as serum 25(OH)D <20 ng/mL 25(OH)D>20 ng/mL	36 participants n=5 Participants	34 participants n=7 Participants	70 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Intention to treat -- participants analyzed based on the group to which they were randomized but only included in the analysis if they had follow up data at 6 months.

Circulating concentration of 25 hydroxyvitamin D is a biomarker of vitamin D status. Vitamin D deficiency was defined as serum 25-hydroxyvitamin D concentrations \<20 ng/mL.

Outcome measures

Outcome measures
Measure	Vitamin D3 Group n=70 Participants Vitamin D3 1000 IU Tablet Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months	Placebo Group n=63 Participants Placebo Tablet Placebo Tablet: Placebo Tablet once daily for 6 months
Serum 25-hydroxyvitamin D	26.7 ng/mL Standard Deviation 7.6	22.4 ng/mL Standard Deviation 7.3

SECONDARY outcome

Timeframe: 6 months

Population: Intention to treat with participants analyzed by the group to which they were assigned but only analyzing those participants with follow up data for PTH at 6 months.

Outcome measures

Outcome measures
Measure	Vitamin D3 Group n=69 Participants Vitamin D3 1000 IU Tablet Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months	Placebo Group n=62 Participants Placebo Tablet Placebo Tablet: Placebo Tablet once daily for 6 months
Parathyroid Hormone (PTH) Dietary Data	35.5 pg/mL Standard Deviation 16.3	33.5 pg/mL Standard Deviation 17.0

SECONDARY outcome

Timeframe: 6 months

Population: Intention to treat with participants analyzed in the group to which they were assigned but only using participants with 6 month OC data available.

Marker of bone formation

Outcome measures

Outcome measures
Measure	Vitamin D3 Group n=70 Participants Vitamin D3 1000 IU Tablet Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months	Placebo Group n=61 Participants Placebo Tablet Placebo Tablet: Placebo Tablet once daily for 6 months
Osteocalcin (OC)	101.1 ng/mL Standard Deviation 48.3	104.8 ng/mL Standard Deviation 48.7

SECONDARY outcome

Timeframe: 6 months

Population: Intention to treat with participants analyzed by the group to which they were assigned but only analyzing participants with 6 month CTx data.

Collagen type 1 cross-linked C-telopeptide (CTx) is a marker of bone resorption.

Outcome measures

Outcome measures
Measure	Vitamin D3 Group n=69 Participants Vitamin D3 1000 IU Tablet Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months	Placebo Group n=63 Participants Placebo Tablet Placebo Tablet: Placebo Tablet once daily for 6 months
Collagen Type 1 Cross-linked C-telopeptide (CTx)	1.4 ng/mL Standard Deviation 0.9	1.6 ng/mL Standard Deviation 0.9

Adverse Events

Vitamin D3 Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

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

Kumaravel Rajakumar

Children's Hospital of Pittsburgh

Phone: 412-692-5822

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place