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Two Vitamin D Dosing Strategies in Children With Chronic Kidney Disease

NCT01909115 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2020-05-19

No results posted yet for this study

Summary

Vitamin D deficiency is common in the general population and more common in children with chronic kidney disease. Vitamin D is very important for bone health, especially in children with chronic kidney disease. To date, several studies using different doses of vitamin D have been tried to correct vitamin D deficiency, but none has been completely successful. The investigators are comparing two different doses of vitamin D to determine which one is more effective at correcting and maintaining normal blood levels of vitamin D. The investigators hypothesize that a higher percentage of children receiving a higher dose of vitamin D will be vitamin D replete at the end of 6 months.

This study will enroll 80 children 9 to 18 years old who have chronic kidney disease (CKD) and can take pills. They will be enrolled from Chronic Renal Insufficiency Clinic, the Hemodialysis Unit, Peritoneal Dialysis Clinic and Transplant Clinic at Children's Healthcare of Atlanta.

Conditions

Interventions

DRUG

1000 IU of Vitamin D3

1000 IU of Vitamin D will be administered in capsule form, once daily.

DRUG

4000 IU of Vitamin D3

4000 IU of Vitamin D will be administered in capsule form, once daily.

Sponsors & Collaborators

  • Children's Healthcare of Atlanta

    collaborator OTHER

  • Emory University

    lead OTHER

Principal Investigators

  • Larry Greenbaum, MD, PhD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-09-26
Completion
2014-09-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01909115 on ClinicalTrials.gov