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

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ClinicalTrials.gov Identifier: NCT00732758
Recruitment Status : Completed
First Posted : August 12, 2008
Results First Posted : October 22, 2015
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
Kumaravel Rajakumar, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Healthy
Interventions Dietary Supplement: Vitamin D3 1000 IU
Dietary Supplement: Placebo Tablet
Enrollment 157
Recruitment Details We enrolled healthy 8- to 14-year-old children from October through March of 2008 through 2011.
Pre-assignment Details 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.
Arm/Group Title Vitamin D3 Group Placebo Group
Hide Arm/Group Description

Vitamin D3 1000 IU Tablet

Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months

Placebo Tablet

Placebo Tablet: Placebo Tablet once daily for 6 months

Period Title: Overall Study
Started 78 79
Completed 70 63
Not Completed 8 16
Reason Not Completed
Lost to Follow-up             8             16
Arm/Group Title Vitamin D3 Group Placebo Group Total
Hide Arm/Group Description

Vitamin D3 1000 IU Tablet

Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months

Placebo Tablet

Placebo Tablet: Placebo Tablet once daily for 6 months

Total of all reporting groups
Overall Number of Baseline Participants 78 79 157
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants 79 participants 157 participants
11.2  (1.9) 11.4  (2.0) 11.3  (1.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 79 participants 157 participants
Female
45
  57.7%
34
  43.0%
79
  50.3%
Male
33
  42.3%
45
  57.0%
78
  49.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 79 participants 157 participants
Hispanic or Latino
1
   1.3%
1
   1.3%
2
   1.3%
Not Hispanic or Latino
68
  87.2%
63
  79.7%
131
  83.4%
Unknown or Not Reported
9
  11.5%
15
  19.0%
24
  15.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 79 participants 157 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
42
  53.8%
42
  53.2%
84
  53.5%
White
36
  46.2%
37
  46.8%
73
  46.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 78 participants 79 participants 157 participants
78 79 157
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kilograms/meters^2
Number Analyzed 78 participants 79 participants 157 participants
21.6  (5.5) 21.6  (6.2) 21.6  (5.85)
Skin Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 78 participants 79 participants 157 participants
I (easy burn, no tan) 4 6 10
II (easy burn, slight tan) 14 13 27
III (burn, then tan) 15 16 31
IV (no burn, good tan) 36 27 63
V (never burn, marked tan) 7 16 23
Unknown 2 1 3
Vitamin D-deficient: Defined as serum 25(OH)D <20 ng/mL  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 78 participants 79 participants 157 participants
25(OH)D<20 ng/mL 42 45 87
25(OH)D>20 ng/mL 36 34 70
1.Primary Outcome
Title Serum 25-hydroxyvitamin D
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Vitamin D3 Group Placebo Group
Hide Arm/Group Description:

Vitamin D3 1000 IU Tablet

Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months

Placebo Tablet

Placebo Tablet: Placebo Tablet once daily for 6 months

Overall Number of Participants Analyzed 70 63
Mean (Standard Deviation)
Unit of Measure: ng/mL
26.7  (7.6) 22.4  (7.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D3 Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments adjusting for baseline 25(OH)D, race, BMI, diet vitamin D, gender, pubertal status, and sunlight exposure.
2.Secondary Outcome
Title Parathyroid Hormone (PTH) Dietary Data
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Vitamin D3 Group Placebo Group
Hide Arm/Group Description:

Vitamin D3 1000 IU Tablet

Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months

Placebo Tablet

Placebo Tablet: Placebo Tablet once daily for 6 months

Overall Number of Participants Analyzed 69 62
Mean (Standard Deviation)
Unit of Measure: pg/mL
35.5  (16.3) 33.5  (17.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D3 Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method t-test, 2 sided
Comments unadjusted p-values
3.Secondary Outcome
Title Osteocalcin (OC)
Hide Description Marker of bone formation
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat with participants analyzed in the group to which they were assigned but only using participants with 6 month OC data available.
Arm/Group Title Vitamin D3 Group Placebo Group
Hide Arm/Group Description:

Vitamin D3 1000 IU Tablet

Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months

Placebo Tablet

Placebo Tablet: Placebo Tablet once daily for 6 months

Overall Number of Participants Analyzed 70 61
Mean (Standard Deviation)
Unit of Measure: ng/mL
101.1  (48.3) 104.8  (48.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D3 Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Collagen Type 1 Cross-linked C-telopeptide (CTx)
Hide Description Collagen type 1 cross-linked C-telopeptide (CTx) is a marker of bone resorption.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat with participants analyzed by the group to which they were assigned but only analyzing participants with 6 month CTx data.
Arm/Group Title Vitamin D3 Group Placebo Group
Hide Arm/Group Description:

Vitamin D3 1000 IU Tablet

Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months

Placebo Tablet

Placebo Tablet: Placebo Tablet once daily for 6 months

Overall Number of Participants Analyzed 69 63
Mean (Standard Deviation)
Unit of Measure: ng/mL
1.4  (0.9) 1.6  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vitamin D3 Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vitamin D3 Group Placebo Group
Hide Arm/Group Description

Vitamin D3 1000 IU Tablet

Vitamin D3 1000 IU: Vitamin D3 1000 IU Tablet once daily for 6 months

Placebo Tablet

Placebo Tablet: Placebo Tablet once daily for 6 months

All-Cause Mortality
Vitamin D3 Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vitamin D3 Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/78 (0.00%)   0/79 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vitamin D3 Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/78 (0.00%)   0/79 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kumaravel Rajakumar
Organization: Children's Hospital of Pittsburgh
Phone: 412-692-5822
EMail: rajakumark@upmc.edu
Layout table for additonal information
Responsible Party: Kumaravel Rajakumar, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00732758     History of Changes
Other Study ID Numbers: 1K23HD052550-01A2 ( U.S. NIH Grant/Contract )
1K23HD052550-01A2 ( U.S. NIH Grant/Contract )
First Submitted: August 7, 2008
First Posted: August 12, 2008
Results First Submitted: September 22, 2015
Results First Posted: October 22, 2015
Last Update Posted: December 29, 2015