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Trial record 5 of 13 for:    asthma | Recruiting, Not yet recruiting, Active, not recruiting, Enrolling by invitation Studies | "vitamin d"

Vitamin D Oral Replacement in Asthma (VDORA1)

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ClinicalTrials.gov Identifier: NCT03686150
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
IDeA States Pediatric Clinical Trials Network

Tracking Information
First Submitted Date  ICMJE September 25, 2018
First Posted Date  ICMJE September 26, 2018
Last Update Posted Date August 20, 2020
Actual Study Start Date  ICMJE January 30, 2019
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2018)
  • Best dosing level of vitamin D supplementation [ Time Frame: 20 weeks ]
    Determine the best vitamin D supplementation level based on PK analysis
  • Part 1: optimal dosing level to use in part 2 [ Time Frame: 20 weeks ]
    Based on part 1 data, determine the best vitamin D supplementation level based on PK analysis
  • Part 2: Proportion of participants with vitamin D levels >= 40 ng/ml [ Time Frame: 16 weeks ]
    Proportion of participants in part 2 who achieve vitamin levels >= 40 ng/ml
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D Oral Replacement in Asthma
Official Title  ICMJE Vitamin D Oral Replacement in Asthma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, parallel arm clinical trial 4 arms in part 1 2 arms in part 2
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Asthma
  • Vitamin D Deficiency
  • Pediatric Obesity
Intervention  ICMJE Dietary Supplement: Vitamin D3 oral regimen
Vitamin D3 oral regimens supplementation
Study Arms  ICMJE
  • Experimental: Part 1, Cohort 1 Vitamin D3 oral regimen
    Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose
    Intervention: Dietary Supplement: Vitamin D3 oral regimen
  • Experimental: Part 1, Cohort 2 Vitamin D3 oral regimen
    Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose
    Intervention: Dietary Supplement: Vitamin D3 oral regimen
  • Experimental: Part 1, Cohort 3 Vitamin D3 oral regimen
    Vitamin D: 6000 IU daily dose
    Intervention: Dietary Supplement: Vitamin D3 oral regimen
  • Active Comparator: Part 1, Cohort 4 Vitamin D3 oral regimen
    Vitamin D: 600 IU daily dose
    Intervention: Dietary Supplement: Vitamin D3 oral regimen
  • Experimental: Part 2, Cohort A Vitamin D3 oral regimen
    Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily doseD
    Intervention: Dietary Supplement: Vitamin D3 oral regimen
  • Active Comparator: Part 2, Cohort B Vitamin D oral regimen
    Vitamin D: 600 IU daily dose
    Intervention: Dietary Supplement: Vitamin D3 oral regimen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 18, 2020)
100
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2018)
89
Estimated Study Completion Date  ICMJE October 31, 2021
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jeannette Y Lee, Ph.D. 501 320 7344 jylee@uams.edu
Contact: Jessica Snowden, MD 501 526 5837 jsnowden@uams.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03686150
Other Study ID Numbers  ICMJE 101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party IDeA States Pediatric Clinical Trials Network
Study Sponsor  ICMJE IDeA States Pediatric Clinical Trials Network
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account IDeA States Pediatric Clinical Trials Network
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP