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Vitamin D Oral Replacement in Asthma (VDORA1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03686150
Recruitment Status : Completed
First Posted : September 26, 2018
Last Update Posted : April 5, 2022
Sponsor:
Information provided by (Responsible Party):
IDeA States Pediatric Clinical Trials Network

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.

Condition or disease Intervention/treatment Phase
Asthma Vitamin D Deficiency Pediatric Obesity Dietary Supplement: Vitamin D3 oral regimen Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
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
Official Title: Vitamin D Oral Replacement in Asthma
Actual Study Start Date : January 30, 2019
Actual Primary Completion Date : September 30, 2021
Actual Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Vitamin D

Arm Intervention/treatment
Experimental: Part 1, Cohort 1 Vitamin D3 oral regimen
Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose
Dietary Supplement: Vitamin D3 oral regimen
Vitamin D3 oral regimens supplementation

Experimental: Part 1, Cohort 2 Vitamin D3 oral regimen
Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose
Dietary Supplement: Vitamin D3 oral regimen
Vitamin D3 oral regimens supplementation

Experimental: Part 1, Cohort 3 Vitamin D3 oral regimen
Vitamin D: 6000 IU daily dose
Dietary Supplement: Vitamin D3 oral regimen
Vitamin D3 oral regimens supplementation

Active Comparator: Part 1, Cohort 4 Vitamin D3 oral regimen
Vitamin D: 600 IU daily dose
Dietary Supplement: Vitamin D3 oral regimen
Vitamin D3 oral regimens supplementation

Experimental: Part 2, Cohort A Vitamin D3 oral regimen
Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily doseD
Dietary Supplement: Vitamin D3 oral regimen
Vitamin D3 oral regimens supplementation

Active Comparator: Part 2, Cohort B Vitamin D oral regimen
Vitamin D: 600 IU daily dose
Dietary Supplement: Vitamin D3 oral regimen
Vitamin D3 oral regimens supplementation




Primary Outcome Measures :
  1. Best dosing level of vitamin D supplementation [ Time Frame: 20 weeks ]
    Determine the best vitamin D supplementation level based on PK analysis

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686150


Locations
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United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, Delaware
Nemours/Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, Hawaii
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40292
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, Montana
Community Medical Center
Missoula, Montana, United States, 59804
United States, Nebraska
University of Nebraska Medical Center/Children's Hospital and Medical Center
Omaha, Nebraska, United States, 68198
United States, New Hampshire
Dartmouth Hospital - Manchester
Manchester, New Hampshire, United States, 03104
United States, New Mexico
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131
United States, Oklahoma
Children's Hospital OU Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29208
United States, Vermont
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
IDeA States Pediatric Clinical Trials Network
  Study Documents (Full-Text)

Documents provided by IDeA States Pediatric Clinical Trials Network:
Informed Consent Form  [PDF] November 2, 2020

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Responsible Party: IDeA States Pediatric Clinical Trials Network
ClinicalTrials.gov Identifier: NCT03686150    
Other Study ID Numbers: 101
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: April 5, 2022
Last Verified: March 2022

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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
Keywords provided by IDeA States Pediatric Clinical Trials Network:
pediatric obesity
Additional relevant MeSH terms:
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Asthma
Vitamin D Deficiency
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents