Effect of Vitamin D Treatment on Fatigue

NCT02022475 | Completed Phase 3 DMC

• 1 other identifier: Kray-1213
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

vitamin D; fatigue

Outcome Measures

Primary Outcomes (1)

• Intraindividual change of Fatigue as quantified by FAS (δFAS) 28 (+maximum 7) days after administering Vitamin D3 (Cholecalciferol)

  28 (+maximum 7) days

Secondary Outcomes (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.

  28 (+maximum 7) days

Other Outcomes (2)

• Efficacy of vitamin D (Cholecalciferol) administration on fatigue using the short self-developed FCA-Test

  28 (+maximum 7) days

• Fibroblast Growth factor 23, sclerostin and soluble Klotho levels before and 28 days after vitamin D administration

  28 (+maximum 7) days

Study Arms (2)

Cholecalciferol

ACTIVE COMPARATOR

100 000 units vitamin D3 single dose

Drug: Vitamin D

Placebo

PLACEBO COMPARATOR

similar appearance

Other: placebo

Interventions

Vitamin D DRUG

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

Also known as: Cholecalciferol

Cholecalciferol

placebo OTHER

2 placebo capsules will be applied as a single dose

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Clinic and policlinic for Inetrnal Medicine

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

• Nowak A, Boesch L, Andres E, Battegay E, Hornemann T, Schmid C, Bischoff-Ferrari HA, Suter PM, Krayenbuehl PA. Effect of vitamin D3 on self-perceived fatigue: A double-blind randomized placebo-controlled trial. Medicine (Baltimore). 2016 Dec;95(52):e5353. doi: 10.1097/MD.0000000000005353.

  PMID: 28033244 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Fatigue

Interventions

Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• Krayenbühl Pierre-Alexander, Dr

  University Hospital Zürich, Department of Internal Medicine

  STUDY DIRECTOR

• Albina Nowak, MD

  University Hospital Zürich, Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: December 27, 2013
• Study Start: December 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 21, 2015

Record last verified: 2015-07

Locations

CH (1)