Evaluation of Colecalciferol Substitution in Dialysis Patients

NCT00397475 | Completed

• 1 other identifier: 142/06
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of a colecalciferol substitution in dialysis patients on bone metabolism and immune system

Conditions

RENAL INSUFFICIENCY, CHRONIC; Hyperparathyroidism, Secondary

Outcome Measures

Primary Outcomes (1)

• CD14/CD16-Monocyte-Subsets (Frequency)

Secondary Outcomes (3)

• Production of Cytokines: IFN-γ, TNF-α

• Serum levels of Calcium, Phosphorus, iPTH, hsCRP, alkaline phosphatase

• Th1/Th2- and Tc1/Tc2-Lymphocyte-Frequency

Interventions

Colecalciferol DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Serum 25-OH-Vit.D-levels \< 60 ng/ml
• Age \> 18 years
• dialysis treatment \> 3 Months
• signed written informed consent
• Serum-Calcium-levels \< 2,6 mmol/l within the last 4 weeks
• Serum-Phosphate-levels \< 7,0 mg/dl within the last 4 weeks
• Ca x P-Product \< 75 mg2/dl2 within the last 4 weeks

You may not qualify if:

• Serum 25-OH-Vit.-D-levels \> 60 ng/ml
• concommitant participation in another interventional trial
• psychiatric disorders preventing from valid informed consent
• Hyperphosphatemia (\> 7,0 mg/dl) within the last 4 weeks
• Hypercalcemia (\> 2,6 mmol/l) within the last 4 weeks
• Ca x P-Product \> 75 mg2/dl2 within the last 4 weeks
• pregnancy or lactation
• known malignancy
• liver disease, defined as 2-fold upper limit of ASAT-, or ALAT-levels
• PTH levels \< 50 pg/ml
• current clinically relevant infections treated with antibiotic therapy and raised hsCRP levels
• Chronic viral Infectious diseases (e.g. HIV, Hepatitis B or C)
• Immunosuppressant Medication
• known hematologic disorders, other than renal anemia
• age below 18 years

Sponsors & Collaborators

• University Hospital, Saarland: lead

Study Sites (1)

University Hospital of Saarland, Dpt. of Internal Medicine IV, Div. of Nephrology and Hypertension

Homburg, Saarland, 66421, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperparathyroidism, Secondary

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Eric Seibert, M.D.

  University Hospital of Saarland, Dpt. of Internal Medicine IV, Div. of Nephrology and Hypertension

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 7, 2006
• First Posted: November 9, 2006
• Study Start: November 1, 2006
• Study Completion: March 1, 2007
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

DE (1)