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Effect of Vitamin D Treatment on Fatigue

NCT02022475 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-07-21

No results posted yet for this study

Summary

Primary objective

-Change in Fatigue Assesment Score (FAS) between the first visit (baseline) and 28 (+maximum 7) days after oral administration of 100 000 E vitamin D (Cholecalciferol).

Secondary objectives

* Effect of oral administration of vitamin D on serum vitamin D levels (25-Hydroxy-Vitamin D = Colecalciferol), PTH, Calcium, and Phosphate as compared to placebo.
* Efficacy of vitamin D (Colecalciferol) administration on fatigue using the short self-developed FCA-Test
* Safety of 100 000 E oral vitamin D (Colecalciferol) administration as compared to oral placebo. Laboratoty parameters such as serum calzium and phosphate levels and the number of adverse events compared to placebo will be used for safety monitoring.
* Efficacy of oral administration of vitamin D (Cholecalciferol) on plasma FGF-23, Sclerostin and Klotho levels compared to placebo.

Conditions

  • Vitamin D Deficiency

Interventions

DRUG

Vitamin D

100 000 units oral vitamin D as 2 capsules 50 000 units each

OTHER

placebo

2 placebo capsules will be applied as a single dose

Sponsors & Collaborators

  • University of Zurich

    lead OTHER

Principal Investigators

  • Krayenbühl Pierre-Alexander, Dr · University Hospital Zürich, Department of Internal Medicine

  • Albina Nowak, MD · University Hospital Zürich, Department of Internal Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-05-31
Completion
2015-06-30

Countries

  • Switzerland

Study Locations

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Entities

Drugs

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 NCT02022475 on ClinicalTrials.gov