Two Vitamin D Dosing Strategies in Children With Chronic Kidney Disease

NCT01909115 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: IRB00067067EmoryPedNeph-001
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1000 IU of Vitamin D Daily

ACTIVE COMPARATOR

Participants randomized to take a 1000 IU capsule of Vitamin D every day for 6 months.

Drug: 1000 IU of Vitamin D3

4000 IU of Vitamin D Daily

EXPERIMENTAL

Participants randomized to take a 4000 IU capsule of Vitamin D capsule every day for 6 months.

Drug: 4000 IU of Vitamin D3

Interventions

1000 IU of Vitamin D3 DRUG

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

1000 IU of Vitamin D Daily

4000 IU of Vitamin D3 DRUG

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

4000 IU of Vitamin D Daily

Eligibility Criteria

• Age: 9 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Estimated glomerular filtration rate \< 60 mL/min/1.73 m2 body surface area or recipient of a kidney transplant
• years old
• Able to swallow pills

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead
• Children's Healthcare of Atlanta: collaborator

Study Sites (1)

Childen's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

• 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.

  PMID: 34392411 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Larry Greenbaum, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatric Nephrology and Division Director of Pediatric Nephrology

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: July 26, 2013
• Study Start: September 1, 2013
• Primary Completion: September 26, 2014
• Study Completion: September 26, 2014
• Last Updated: May 19, 2020

Record last verified: 2020-05

Locations

US (1)