Vitamin D Supplementation in Children with Obesity-Related Asthma (VDORA1)

About this Study

The purpose of the study is to learn more about Vitamin D levels in children who have asthma and are overweight or obese. 

Sponsor Protocol ID:228446
IRB Number:2019-0090
Closed for Enrollment
Interventional
Early Phase 1
June 28, 2019
Eligibility Criteria
6 years old
18 years old
Both Male and Female
No
Yes
Yes

Inclusion Criteria
  • Greater than or equal to 6 and less than 18 years of age at Visit 1.
  • BMI greater than or equal to 85% for age and sex
  • Physician-diagnosed asthma
  • Ongoing relationship with asthma provider responsible for asthma care (can be specialist or primary care provider)
  • Ability to swallow pills similar in size to the vitamin D preparation to be used (Vitamin D supplements will be provided in the form of a size 2 capsule.  See Section 6.2.2 for additional information.)
  • Signed consent from his or her parent, legal guardian, or caregiver and signed assent from participant (as appropriate)
  • Femailes of child-bearing potential must not be pregnant, must not be lactating, and must agree to practice adequate birth control (abstinence), single barrier methods, combination barrier and spermicide, or hormonal) for the duration of the study
  • 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
  • Active tuberculosis
  • Clinical evidence of rickets
  • Plans to move out of the study area in the next 9 months
  • There is another child in the household enrolled in the study
  • Plans for significant lifestyle changes in the next 9 months (significant dietary changes while enrolled in the study)
  • Participants who are eligible for the run-in period will be eligible for enrollment if they demonstrate adherence to run-in procedures (complete and return greater than or equal to 75% of run-in daily diary cards)

Categories Click category to view its trials.
Pediatrics
Weight Management
Participating Locations
Children’s of Mississippi Hospital - Blair E. Batson Tower
Jackson Medical Mall - UMMC Clinics
Pavilion - UMMC
Contact Information
Contact Name: Lacy Malloch
Phone Number: 601-815-4517
Email: lmalloch@umc.edu
Principal Investigator:Josey, David, M.D.
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