Effect of Vitamin D Supplementation on Coronary Calcification and Parathyroid Hormone in CKD Patients

NCT01672047 | Unknown DMC

• 1 other identifier: PURCP201103
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that the chronic kidney disease patients who suffer from vitamin D deficiency will be benefit from given Vitamin D2 because coronary artery calcification and hyperparathyroidism will be improved.

Conditions

Chronic Kidney Disease; Vitamin D Deficiency

Keywords

The 25(OH) vitamin D level; The 1.25(OH) vitamin D level; The intact PTH level; The calcification score of coronary artery; The microalbuminuria level

Outcome Measures

Primary Outcomes (1)

• the improvement of coronary artery calcification

  We use CT to detect the coronary artery calcification score in the chronic kidney disease patients for 3 times (baseline, 12 month and 24 month). We will compare the 2 arms （treatment or not）to know if there is any difference。

  2 years

Secondary Outcomes (1)

• the improvement of proteinuria

  2 years

Study Arms (2)

Treament

EXPERIMENTAL

Intervention Vitamin D2

Drug: Vitamin D2

Control

NO INTERVENTION

Not take Vitamin D2

Interventions

Vitamin D2 DRUG

25（OH）D level \<12 nmol/L 50000IU/weekX12week， 12-39 nmol/L 50000IU/weekX4week then，50000IU/month， 40-75 nmol/L 50000IU/month， 75-116.75nmol/L 25000IU/month， \>116.75nmol/L stopped.

Also known as: Vitmain D2 capsule

Treament

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic kidney disease patients (3-5D)
• serum 25（OH）D \< 40nmol/L(16ng/ml)，serum calcium \< 2.55mmol/L（10.2mg/dL）；
• willing to sign
• could obey the follow up design

You may not qualify if:

• allergy to vitamin D
• heart failure (NYHA more than 2 grade)
• pregnant
• malignant tumor
• critical hepatic disease
• taking Vitamin D or analogue in 3 recent months
• taking other clinical trial

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

The People's Hospital of Peking University

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Vitamin D Deficiency

Interventions

Ergocalciferols

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; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Mei Wang, MD, PhD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 24, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: December 1, 2015
• Last Updated: August 30, 2012

Record last verified: 2012-08

Locations

CN (1)