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25-Hydroxyvitamin D Pharmacokinetic Study

NCT03401541 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-06-04

No results posted yet for this study

Summary

To evaluate the pharmacokinetic parameters of orally administered 25-hydroxyvitamin D3 \[25(OH)D3\] and vitamin D3 from the corresponding serum concentration-time curves in healthy adults and adults with a history of intestinal malabsorption.

Conditions

  • Vitamin D Deficiency
  • Fat Malabsorption

Interventions

DRUG

Calcifediol

One capsule of 900 micrograms of 25(OH)D

DRUG

Calciferol

One capsule of 900 micrograms of Vitamin D

Sponsors & Collaborators

  • Boston University

    lead OTHER

Principal Investigators

  • Michael F Holick, MD, PhD · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2019-04-01
Completion
2019-11-01
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 NCT03401541 on ClinicalTrials.gov