Vitamin D Oral Replacement in Asthma

Not Applicable

Completed

• Conditions: Pediatric Obesity; Vitamin D Deficiency; Asthma
• Interventions: Dietary Supplement: Vitamin D3 oral regimen

• Registration Number: NCT03686150
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-09-25
• Study First Posted: 2018-09-26
• Study Start: 2019-01-30
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Results First Submitted: 2022-09-27
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Results First Posted: 2023-04-19
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1, Cohort 4 Vitamin D3 oral regimen	Vitamin D3 oral regimen	Vitamin D: 600 IU daily dose
Part 1, Cohort 3 Vitamin D3 oral regimen	Vitamin D3 oral regimen	Vitamin D: 6000 IU daily dose
Part 2, Cohort A Vitamin D3 oral regimen	Vitamin D3 oral regimen	Vitamin D: Single 50,000 IU loading dose + 8,000 IU daily doseD
Part 1, Cohort 1 Vitamin D3 oral regimen	Vitamin D3 oral regimen	Intervention: Vitamin D: Single 50,000 IU loading dose + 6000 IU daily dose
Part 1, Cohort 2 Vitamin D3 oral regimen	Vitamin D3 oral regimen	Vitamin D: Single 50,000 IU loading dose + 10,000 IU daily dose
Part 2, Cohort B Vitamin D oral regimen	Vitamin D3 oral regimen	Vitamin D: 600 IU daily dose

Primary Outcome Measures

Name	Time	Method
Part 1: Optimal Dosing Level to Use in Part 2	20 weeks	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	16 weeks	Proportion of participants in part 2 who achieve vitamin levels \>= 40 ng/ml

Trial Locations

Locations (15)

West Virginia University; 🇺🇸 Morgantown, West Virginia, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

Community Medical Center; 🇺🇸 Missoula, Montana, United States

University of Nebraska Medical Center/Children's Hospital and Medical Center; 🇺🇸 Omaha, Nebraska, United States

Children's Hospital OU Medical Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States

Nemours/Alfred I duPont Hospital for Children; 🇺🇸 Wilmington, Delaware, United States

Dartmouth Hospital - Manchester; 🇺🇸 Manchester, New Hampshire, United States

University of New Mexico Health Sciences Center; 🇺🇸 Albuquerque, New Mexico, United States

University of South Carolina; 🇺🇸 Columbia, South Carolina, United States

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States

University of Vermont Medical Center; 🇺🇸 Burlington, Vermont, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States

Kapiolani Medical Center for Women and Children; 🇺🇸 Honolulu, Hawaii, United States