Study of Vitamin D3 Supplementation in Patients With Chronic Kidney Disease

NCT00893451 | Completed DMC

• 1 other identifier: VitaD-CKD1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the impact of vitamin D3 supplementation on the insulin resistance in non-diabetic patients with chronic kidney disease (CKD) stages 3-4, vitamin D deficiency/insufficiency and elevated fasting serum insulin levels.

Conditions

Chronic Kidney Disease; Insulin Resistance; Vitamin D Deficiency

Keywords

renal disease; renal impairment; chronic kidney disease stage 3-4; 25(OH) vitamin D; cholecalciferol; vitamin D deficiency; insulin resistance; insulin-glucose clamp; non-diabetic

Outcome Measures

Primary Outcomes (1)

• Change in M-value (mg/kg lean body mass/min) assessed by insulin-glucose clamp

  at week 26

Secondary Outcomes (4)

• Change in systolic- and diastolic blood pressure

  at week 26

• Change in PTH secretion and its fragments assessed by PTH, CAP-PTH, CIP-PTH

  at week 26

• Change in insulin secretion assessed by intravenous glucose tolerance test

  at week 26

• Change in urinary excretion of albumin (UAE) assessed by 24 hour collection

  at week 26

Study Arms (2)

A

ACTIVE COMPARATOR

Vitamin D3 1600 IU orally twice daily

Drug: cholecalciferol (TillVal-D)

B

PLACEBO COMPARATOR

Placebo orally twice daily

Drug: Placebo

Interventions

cholecalciferol (TillVal-D) DRUG

In a randomized, two-way cross-over design participants will take vitamin D3 or placebo twice daily during treatment periods of 10 weeks separated by a washout period of 6 weeks.

Also known as: TillVal-D, cholecalciferol, vitamin D3

A

Placebo DRUG

Placebo orally twice daily

B

Eligibility Criteria

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

You may qualify if:

• Male or female, age older than 18 years
• Non-diabetic chronic kidney disease stage 3 and 4 (GFR 15-60 ml/min/1.73 m2)
• Serum 25(OH) vitamin D \< 30 ng/mL (75 nmol/L)
• Fasting S-insulin \> 30 IU/L
• Written informed consent before entered into study

You may not qualify if:

• Patients with current significant, major or unstable cardio-cerebrovascular, infection, respiratory, gastrointestinal or other major disease and risks according to the judgment made by the investigator
• Patients with type 1 or type 2 Diabetes
• Current severe thyrotoxicosis or other endocrine disease
• Granulomatous disease, such as sarcoidosis and tuberculosis
• Patients who are intended to receive hemodialysis (HD), peritoneal dialysis (PD) or being kidney transplanted during the course of study (9 months)
• Concomitant use of corticosteroids (except for inhalation or topical use) or other immunosuppressive medication
• Treatment with biphosphonate during last two years
• S-Calcium \> 2.70 mmol/L (0.68 mg/dl)
• PTH intact \< 75 ng/L (8.25 nmol/L) or \> 800 ng/L (88 nmol/L)
• Proteinuria \> 3.5 g/24 hours
• Alcohol or drug abuse or any condition associated with poor compliance
• Blood donors
• Women of childbearing potential, desired pregnancy, pregnancy or lactation within the study period
• Allergy or intolerance to cholecalciferol supplementation (TillVal D®) or other constituents
• History of kidney stones

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Department of Kidney diseases, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Insulin Resistance; Vitamin D Deficiency; Kidney Diseases; Renal Insufficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

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; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hamid R Dezfoolian, MD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 5, 2009
• First Posted: May 6, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 10, 2011

Record last verified: 2011-06

Locations

SE (1)