Effect of Vitamin D Treatment on Fatigue

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Zurich
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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