Effect of Vitamin D Treatment on Fatigue

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT02022475
First received: December 12, 2013
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.

Condition Intervention Phase
Vitamin D Deficiency
Drug: Vitamin D
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Peroral Vitamin D Versus Placebo on Self-reported Fatigue in Adults With Low 25-hydroxy-vitamin D Levels

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Intraindividual change of Fatigue as quantified by FAS (δFAS) 28 (+maximum 7) days after administering Vitamin D3 (Cholecalciferol) [ Time Frame: 28 (+maximum 7) days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of oral administration of vitamin D on serum vitamin D levels (25-Hydroxy-Vitamin D = Cholecalciferol), PTH, Calcium, and Phosphate as compared to placebo. [ Time Frame: 28 (+maximum 7) days ] [ Designated as safety issue: No ]
    Blood samples will be drawn, urine samples will be taken prior to and 28 (+maximum 7) days after the vitamin D administration.


Other Outcome Measures:
  • Efficacy of vitamin D (Cholecalciferol) administration on fatigue using the short self-developed FCA-Test [ Time Frame: 28 (+maximum 7) days ] [ Designated as safety issue: No ]

    Fatigue course assessment (FCA)

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  • Fibroblast Growth factor 23, sclerostin and soluble Klotho levels before and 28 days after vitamin D administration [ Time Frame: 28 (+maximum 7) days ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cholecalciferol
100 000 units vitamin D3 single dose
Drug: Vitamin D
100 000 units oral vitamin D as 2 capsules 50 000 units each
Other Name: Cholecalciferol
Placebo Comparator: Placebo
similar appearance
Other: placebo
2 placebo capsules will be applied as a single dose

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 18-25 kg/m2
  • Serum 25-Hydroxy-Vitamin D level < 20 mkg/l
  • Adequate contraception during the study period
  • Informed consent

Exclusion Criteria:

  • Anemia with Hb level < 120 g/l
  • Known hypersensitivity to vitamin D
  • Intake of vitamin D preparations (including) during the last 8 weeks before the start of the trial protocol
  • Pregnancy or lactation or intention to become pregnant during the course of the study
  • Any cardiovascular, pulmonary, renal or hepatic disease
  • Presence of muscle disease, CK>167 U/L
  • Presence of known bone disease, alkaline phosphatase > 104 U/l
  • Severe infection/inflammation or malignancy
  • Known mental disorders (e.g. depression), sleep disorders
  • Chronic intake of concurrent medication, except oral contraceptives. Sporadic intake of NSAID or paracetamol, e.g. in the case of a common cold or sporadic headaches is allowed.
  • CRP > 10 mg/l
  • TSH out of normal range
  • Ferritin <15 µg/L
  • Any concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the participants.
  • Participation in any other therapeutic trial within the previous month
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia etc.
  • Enrollment of the investigator, his/her family members, employees and other dependent persons
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02022475

Contacts
Contact: Albina Nowak, MD 0041 44 255 1111 ext 1054 albina.nowak@usz.ch

Locations
Switzerland
Clinic and policlinic for Inetrnal Medicine Recruiting
Zürich, Switzerland, 8091
Sub-Investigator: Lukas Boesch, Postgraduate         
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: Krayenbühl Pierre-Alexander, Dr University Hospital Zürich, Department of Internal Medicine
Principal Investigator: Albina Nowak, MD University Hospital Zürich, Department of Internal Medicine
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02022475     History of Changes
Other Study ID Numbers: Kray-1213
Study First Received: December 12, 2013
Last Updated: August 12, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
vitamin D
fatigue

Additional relevant MeSH terms:
Vitamin D Deficiency
Fatigue
Signs and Symptoms
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 01, 2014