Clearance of 25-hydroxyvitamin D3 During Vitamin D3 Supplementation

• Status: Completed
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to determine how 25(OH)D3 clearance is affected by vitamin D3 supplementation using a gold standard pharmacokinetic approach.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Calcifediol; Cholecalciferol; Ergocalciferols; Hydroxycholecalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Successful prior completion of related protocol CLEAR (NCT02937350) or CLEAR-CF (NCT03104855)

• Age ≥ 18 years

• Self-reported race Caucasian, African American, or African

Exclusion Criteria:

• Primary hyperparathyroidism

• Gastric bypass

• Tuberculosis or sarcoidosis

• Current pregnancy

• Child-Pugh Class B or C cirrhosis (i.e. cirrhosis with ascites, hepatic encephalopathy, bilirubin >=2 mg/dL, serum albumin <=3.5 g/dL, or PT >= 4 seconds)

• History of kidney transplantation (unless failed transplant now treated with hemodialysis)

• Use of 1,25(OH)2D3 or an analogue, calcimimetics, or medications known to induce CYP24A1 within 4 weeks (wash-out allowed)

• Serum calcium > 10.1 mg/dL

• Hemoglobin < 10 g/dL