Vitamin D Oral Replacement in Asthma

Asthma Clinical Trial

— VDORA1  

Official title:

Vitamin D Oral Replacement in Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03686150
• Other study ID #: 101
• Secondary ID: U24OD024957
• Status: Completed
• Phase: N/A
• Start date: January 30, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2023
• Source: IDeA States Pediatric Clinical Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Pediatric Obesity
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D3 oral regimen
Vitamin D3 oral regimens supplementation

Locations

Country	Name	City	State
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	University of Vermont Medical Center	Burlington	Vermont
United States	University of South Carolina	Columbia	South Carolina
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	University of Louisville	Louisville	Kentucky
United States	Dartmouth Hospital - Manchester	Manchester	New Hampshire
United States	Community Medical Center	Missoula	Montana
United States	West Virginia University	Morgantown	West Virginia
United States	Children's Hospital OU Medical Center	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center/Children's Hospital and Medical Center	Omaha	Nebraska
United States	Nemours/Alfred I duPont Hospital for Children	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
IDeA States Pediatric Clinical Trials Network	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	20 weeks
Primary	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	16 weeks