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Safety, Efficacy, and Feasibility of High-dose Cholecalciferol in Pediatric Patients With Cystic Fibrosis

NCT02613884 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-02-03

Study results available
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Summary

Children with Cystic Fibrosis, ages greater than and equal to 36 months of age and less than or equal to 18 years of age, with a 25OHD level less than 30 ng/dL will be asked to participate in this study. Upon consent, they will be given oral cholecalciferol supplementation of 250,000 IU during their next CF clinic visit. The safety will be assessed by measuring a serum calcium level within 1 week of supplementation. Efficacy will be assessed using repeated 25OHD levels throughout the course of 12 months. Feasibility will be assessed with the previous two measures as well as a brief questionnaire administered via telephone within 1 week of supplementation.

Conditions

  • Vitamin D Deficiency

Interventions

DRUG

Treatment

Sponsors & Collaborators

  • Johns Hopkins All Children's Hospital

    lead OTHER

Principal Investigators

  • Deanna Green, MD · Johns Hopkins All Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
36 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-11-25
Completion
2019-11-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02613884 on ClinicalTrials.gov