Two Vitamin D Dosing Strategies in Children With Chronic Kidney Disease

Randomized Trial of Two Maintenance Doses of Vitamin D and Trace Element Status in Children With Chronic Kidney Disease

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: 1000 IU of Vitamin D3; Drug: 4000 IU of Vitamin D3

Detailed Description

Vitamin D has a critical role in bone metabolism. In addition, there is increasing evidence that vitamin D has an important role in many other areas, including cardiovascular health, immune function, and prevention of autoimmune diseases and certain malignancies. In patients with CKD, there are a variety of abnormalities in mineral metabolism that lead to bone disease.

After the investigators obtain informed consent and assent, children will be randomly assigned to either low dose (1000 units daily) or high dose (4000 units daily) vitamin D pills (50% in each group). Participants will take vitamin D capsules every day for for 6 months. Vitamin D levels will be obtained at baseline, 3 months and 6 months. The study visits will be at the same time as routine clinic visits when the children are having blood drawn for routine care. At the end of the study, the investigators will compare the percentage of patients who have normal vitamin D levels at 6 months in the two groups. The investigators will also describe the percentage of patients who have elevated or low levels of trace elements.

The two doses of vitamin D in this study are within the dosing range recommended by the Institute of Medicine, and thus the investigators do not anticipate any adverse effects. Vitamin D toxicity could theoretically occur, and an elevated vitamin D level at 3 months would be an indication to withdraw a patient from the study.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Childen's Healthcare of Atlanta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient's parent/legal guardian must be willing and able to give written informed consent and the patient must be willing to give written informed assent if applicable
2. Estimated glomerular filtration rate < 60 mL/min/1.73 m2 body surface area or recipient of a kidney transplant
3. 9-21 years old
4. Able to swallow pills

Exclusion Criteria:

1. Liver failure
2. Malabsorption
3. Current calcium level >10.5 mg/dL
4. History of hypercalcemia (Ca >11 mg/dL) during the preceding 6 months
5. Current treatment with an antiepileptic drug or other medications that may affect vitamin D metabolism (e.g., phenobarbital, phenytoin, rifampicin)
6. History of hypervitaminosis D
7. Completion of a course of high dose vitamin D within the preceding 2 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1000 IU of Vitamin D Daily; Participants randomized to take a 1000 IU capsule of Vitamin D every day for 6 months.	Drug: 1000 IU of Vitamin D3; 1000 IU of Vitamin D will be administered in capsule form, once daily.
Experimental: 4000 IU of Vitamin D Daily; Participants randomized to take a 4000 IU capsule of Vitamin D capsule every day for 6 months.	Drug: 4000 IU of Vitamin D3; 4000 IU of Vitamin D will be administered in capsule form, once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Adequate Vitamin D Level	Vitamin D sufficiency will be assessed as the percentage of participants with a vitamin D level >30 ng/ml.	Month 6

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Children's Healthcare of Atlanta
• Investigators: Principal Investigator: Larry Greenbaum, MD, PhD, Emory University

Publications and helpful links

General Publications

• Nadeem S, Tangpricha V, Ziegler TR, Rhodes JE, Leong T, Xiang Y, Greenbaum LA. Randomized trial of two maintenance doses of vitamin D in children with chronic kidney disease. Pediatr Nephrol. 2022 Feb;37(2):415-422. doi: 10.1007/s00467-021-05228-z. Epub 2021 Aug 15.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): September 26, 2014
• Study Completion (Actual): September 26, 2014

Study Registration Dates

• First Submitted: July 24, 2013
• First Submitted That Met QC Criteria: July 25, 2013
• First Posted (Estimate): July 26, 2013

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 17, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: IRB00067067; EmoryPedNeph-001 (Other Identifier: Other)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No