Vitamin D Oral Replacement in Asthma

NCT03686150 | Completed Results DMC

• 2 other identifiers: 101U24OD024957
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 15

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.

Conditions

Asthma; Vitamin D Deficiency; Pediatric Obesity

Keywords

pediatric obesity

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (6)

Part 1, Cohort 1 Vitamin D3 oral regimen

EXPERIMENTAL

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

Dietary Supplement: Vitamin D3 oral regimen

Part 1, Cohort 2 Vitamin D3 oral regimen

EXPERIMENTAL

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

Dietary Supplement: Vitamin D3 oral regimen

Part 1, Cohort 3 Vitamin D3 oral regimen

EXPERIMENTAL

Vitamin D: 6000 IU daily dose

Dietary Supplement: Vitamin D3 oral regimen

Part 1, Cohort 4 Vitamin D3 oral regimen

ACTIVE COMPARATOR

Vitamin D: 600 IU daily dose

Dietary Supplement: Vitamin D3 oral regimen

Part 2, Cohort A Vitamin D3 oral regimen

EXPERIMENTAL

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

Dietary Supplement: Vitamin D3 oral regimen

Part 2, Cohort B Vitamin D oral regimen

ACTIVE COMPARATOR

Vitamin D: 600 IU daily dose

Dietary Supplement: Vitamin D3 oral regimen

Interventions

Vitamin D3 oral regimen DIETARY_SUPPLEMENT

Vitamin D3 oral regimens supplementation

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

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IDeA States Pediatric Clinical Trials Network: lead
• National Institutes of Health (NIH): collaborator

Study Sites (15)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Nemours/Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

University of Louisville

Louisville, Kentucky, 40292, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Community Medical Center

Missoula, Montana, 59804, United States

Location

University of Nebraska Medical Center/Children's Hospital and Medical Center

Omaha, Nebraska, 68198, United States

Location

Dartmouth Hospital - Manchester

Manchester, New Hampshire, 03104, United States

Location

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Location

Children's Hospital OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Related Publications (2)

• 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.

  PMID: 32930511 BACKGROUND

• Lang JE, Ramirez RG, Balevic S, Bickel S, Hornik CP, Majure JM, Venkatachalam S, Snowden J, O'Sullivan B, James L. Pharmacokinetics of Oral Vitamin D in Children with Obesity and Asthma. Clin Pharmacokinet. 2023 Nov;62(11):1567-1579. doi: 10.1007/s40262-023-01285-9. Epub 2023 Aug 30.

  PMID: 37646988 DERIVED

MeSH Terms

Conditions

Asthma; Vitamin D Deficiency; Pediatric Obesity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Songthip Ounpraseuth
• Organization: University of Arkansas for Medical Sciences

stounpraseuth@uams.edu

501-686-7233

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Randomized, parallel arm clinical trial 4 arms in part 1 2 arms in part 2

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 26, 2018
• Study Start: January 30, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: April 19, 2023
• Results First Posted: April 19, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Anticipated date of data upload is September 2023
• Access Criteria: per DASH requirements

Locations

US (15)