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Effect of Vitamin D Treatment on Fatigue

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ClinicalTrials.gov Identifier: NCT02022475
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief 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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Drug: Vitamin D Other: placebo Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue Vitamin D

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Intraindividual change of Fatigue as quantified by FAS (δFAS) 28 (+maximum 7) days after administering Vitamin D3 (Cholecalciferol) [ Time Frame: 28 (+maximum 7) days ]

Secondary Outcome Measures :
  1. 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 ]
    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:
  1. Efficacy of vitamin D (Cholecalciferol) administration on fatigue using the short self-developed FCA-Test [ Time Frame: 28 (+maximum 7) days ]

    Fatigue course assessment (FCA)

    Wie würden Sie ihre momentane Müdigkeit/Erschöpfung im Vergleich zur Situation vor der Behandlung beschreiben?

    Beschwerdefrei Besser Unverändert Schlechter Deutlich schlechter


  2. Fibroblast Growth factor 23, sclerostin and soluble Klotho levels before and 28 days after vitamin D administration [ Time Frame: 28 (+maximum 7) days ]


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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022475


Locations
Switzerland
Clinic and policlinic for Inetrnal Medicine
Zürich, Switzerland, 8091
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02022475     History of Changes
Other Study ID Numbers: Kray-1213
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

Keywords provided by University of Zurich:
vitamin D
fatigue

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