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Vitamin D Oral Replacement in Asthma (VDORA1)

Primary Purpose

Asthma, Vitamin D Deficiency, Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3 oral regimen
Sponsored by
IDeA States Pediatric Clinical Trials Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring pediatric obesity

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Body mass index greater than or equal to 85% for age and sex
  • Physician-diagnosed asthma
  • Ongoing relationship with asthma provider responsible for asthma care
  • Serum 25(OH) D level 10 ng/ml to less than 30 ng/ml at screening visit based on local laboratory test
  • Ability to swallow pills similar in size to the vitamin D preparation to be used
  • Signed consent form from parent, legal guardian or caregiver and signed assent from participant (as appropriate)
  • Females of childbearing years must not be pregnant, must not be lactating and must agree to practice adequate birth control method
  • Child and parent, legal guardian, or caregiver must speak English or Spanish

Exclusion Criteria:

  • Known diseases of calcium metabolism or the parathyroid
  • History of renal insufficiency or kidney stones
  • Known liver failure or history of abnormal liver function tests
  • History of Williams syndrome, sarcoidosis, or granulomatous disease
  • Active tuberculosis
  • Spot urine calcium/creatinine ration greater than 0.37 (calcium and creatinine measured in mg/ml). This can be repeated following adequate hydration
  • Clinical evidence of rickets
  • Taking supplemental vitamin D greater than equal to 1000 IU per day

Sites / Locations

  • Arkansas Children's Hospital
  • Nemours/Alfred I duPont Hospital for Children
  • Kapiolani Medical Center for Women and Children
  • University of Louisville
  • Pennington Biomedical Research Center
  • University of Mississippi Medical Center
  • Children's Mercy Hospital
  • Community Medical Center
  • University of Nebraska Medical Center/Children's Hospital and Medical Center
  • Dartmouth Hospital - Manchester
  • University of New Mexico Health Sciences Center
  • Children's Hospital OU Medical Center
  • University of South Carolina
  • University of Vermont Medical Center
  • West Virginia University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Part 1, Cohort 1 Vitamin D3 oral regimen

Part 1, Cohort 2 Vitamin D3 oral regimen

Part 1, Cohort 3 Vitamin D3 oral regimen

Part 1, Cohort 4 Vitamin D3 oral regimen

Part 2, Cohort A Vitamin D3 oral regimen

Part 2, Cohort B Vitamin D oral regimen

Arm Description

Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose

Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose

Vitamin D: 6000 IU daily dose

Vitamin D: 600 IU daily dose

Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily doseD

Vitamin D: 600 IU daily dose

Outcomes

Primary Outcome Measures

Part 1: Optimal Dosing Level to Use in Part 2
Determine the best vitamin D supplementation level based on PK analysis of participants enrolled in Part 1. The PK of 25(OH)D after vitamin D supplementation in children will be characterized using a 2-compartment population PK model (popPK) with linear absorption and elimination kinetics.
Part 2: Proportion of Participants With Vitamin D Levels >= 40 ng/ml
Proportion of participants in part 2 who achieve vitamin levels >= 40 ng/ml

Secondary Outcome Measures

Full Information

First Posted
September 25, 2018
Last Updated
March 27, 2023
Sponsor
IDeA States Pediatric Clinical Trials Network
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03686150
Brief Title
Vitamin D Oral Replacement in Asthma
Acronym
VDORA1
Official Title
Vitamin D Oral Replacement in Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 30, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IDeA States Pediatric Clinical Trials Network
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The overall objective of the study is to determine the pharmacokinetics of Vitamin D supplementation in children who have asthma and are overweight or obese.
Detailed Description
This study has two parts. In part 1, study participants will be randomized to receive one of four doses of vitamin D supplementation in international units (IU) over at 16-week period: 1) Single 50,000 IU loading dose + 6000 IU daily dose; 2) Single 50,000 IU loading dose + 10,000 IU daily dose: 3) 6000 IU daily dose; or 4) 600 IU daily dose. Based on pharmacokinetic analysis, one of the doses (1-3) will be selected to use in part 2. In part 2, study participants will be randomized to the dose selected in part 1 or the 600 IU daily dose of vitamin D supplementation to be administered over a 16-week dosing period. Across both parts, safety of each dose regimen of vitamin D supplementation will be evaluated, and the effectiveness of each dose to achieve a serum level of 25(OH)D greater than or equal to 40 ng/ml will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Vitamin D Deficiency, Pediatric Obesity
Keywords
pediatric obesity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, parallel arm clinical trial 4 arms in part 1 2 arms in part 2
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1, Cohort 1 Vitamin D3 oral regimen
Arm Type
Experimental
Arm Description
Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose
Arm Title
Part 1, Cohort 2 Vitamin D3 oral regimen
Arm Type
Experimental
Arm Description
Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose
Arm Title
Part 1, Cohort 3 Vitamin D3 oral regimen
Arm Type
Experimental
Arm Description
Vitamin D: 6000 IU daily dose
Arm Title
Part 1, Cohort 4 Vitamin D3 oral regimen
Arm Type
Active Comparator
Arm Description
Vitamin D: 600 IU daily dose
Arm Title
Part 2, Cohort A Vitamin D3 oral regimen
Arm Type
Experimental
Arm Description
Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily doseD
Arm Title
Part 2, Cohort B Vitamin D oral regimen
Arm Type
Active Comparator
Arm Description
Vitamin D: 600 IU daily dose
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3 oral regimen
Intervention Description
Vitamin D3 oral regimens supplementation
Primary Outcome Measure Information:
Title
Part 1: Optimal Dosing Level to Use in Part 2
Description
Determine the best vitamin D supplementation level based on PK analysis of participants enrolled in Part 1. The PK of 25(OH)D after vitamin D supplementation in children will be characterized using a 2-compartment population PK model (popPK) with linear absorption and elimination kinetics.
Time Frame
20 weeks
Title
Part 2: Proportion of Participants With Vitamin D Levels >= 40 ng/ml
Description
Proportion of participants in part 2 who achieve vitamin levels >= 40 ng/ml
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body mass index greater than or equal to 85% for age and sex Physician-diagnosed asthma Ongoing relationship with asthma provider responsible for asthma care Serum 25(OH) D level 10 ng/ml to less than 30 ng/ml at screening visit based on local laboratory test Ability to swallow pills similar in size to the vitamin D preparation to be used Signed consent form from parent, legal guardian or caregiver and signed assent from participant (as appropriate) Females of childbearing years must not be pregnant, must not be lactating and must agree to practice adequate birth control method Child and parent, legal guardian, or caregiver must speak English or Spanish Exclusion Criteria: Known diseases of calcium metabolism or the parathyroid History of renal insufficiency or kidney stones Known liver failure or history of abnormal liver function tests History of Williams syndrome, sarcoidosis, or granulomatous disease Active tuberculosis Spot urine calcium/creatinine ration greater than 0.37 (calcium and creatinine measured in mg/ml). This can be repeated following adequate hydration Clinical evidence of rickets Taking supplemental vitamin D greater than equal to 1000 IU per day
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Nemours/Alfred I duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Community Medical Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
University of Nebraska Medical Center/Children's Hospital and Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Dartmouth Hospital - Manchester
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03104
Country
United States
Facility Name
University of New Mexico Health Sciences Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Children's Hospital OU Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be uploaded to Data and Specimen Hub (DASH) of NICHD
IPD Sharing Time Frame
Anticipated date of data upload is September 2023
IPD Sharing Access Criteria
per DASH requirements
Citations:
PubMed Identifier
32930511
Citation
O'Sullivan BP, James L, Majure JM, Bickel S, Phan LT, Serrano Gonzalez M, Staples H, Tam-Williams J, Lang J, Snowden J; IDeA States Pediatric Clinical Trials Network. Obesity-related asthma in children: A role for vitamin D. Pediatr Pulmonol. 2021 Feb;56(2):354-361. doi: 10.1002/ppul.25053. Epub 2020 Dec 8.
Results Reference
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Vitamin D Oral Replacement in Asthma

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