Vitamin D Oral Replacement in Asthma

Completed · Not applicable

Conditions studied: Asthma, Vitamin D Deficiency, Pediatric Obesity

In brief

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.

Key facts

Study ID

NCT03686150

Run by

IDeA States Pediatric Clinical Trials Network

People needed

112

Starts

2019-01-30

Expected to finish

2021-09-30

Last updated by the study team

2023-04-19

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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