Cholecalciferol (Vitamin D3) Therapy in Chronic Kidney Disease (CKD) Subjects

NCT00427037 | Completed Results

• 1 other identifier: Vitamin D-2006
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 12 week pilot and feasibility study with an enrollment goal of 30 subjects. Half of the subjects will be randomized to vitamin D3 and the other half will receive a placebo. Subjects will be referred from the nutrition or renal clinic at Emory. CKD stage 3 and 4 patients will be eligible for participation if they have been determined to have vitamin D deficiency and are not on treatment with vitamin D or vitamin D analogues. Subjects will sign an informed consent form after reviewing the protocol in detail with the principal investigator. A questionnaire would collect information about dietary vitamin D intake, sunlight exposure, and any symptoms of vitamin D deficiency. The subject will have baseline levels of serum vitamin D (25-hydroxyvitamin D), parathyroid hormone (PTH), serum calcium and phosphate, creatinine and other markers of bone turnover. The questionnaires and the blood draws would be repeated on the 6th and 12th week of the study. Subjects will be given 12 pills of each containing either 50,000 IU vitamin D or placebo and asked to take one pill a week. They would be scheduled to return to the clinic after 6 weeks and blood measurements would be repeated. Subjects will be asked to revisit for their final visit at the 12th week when they would have their last blood draw and assessment.

Conditions

Chronic Kidney Disease; Vitamin D Deficiency

Keywords

Vitamin D deficiency; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 25-hydroxyvitamin D

  25-hydroxyvitamin D measured in serum by ELISA

  3 months

Secondary Outcomes (1)

• Bone Turnover Marker-CTX

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Cholecalciferol

ACTIVE COMPARATOR

D3

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

50,000 IU weekly by mouth

Also known as: Vitamin D3 is cholecalciferol

Cholecalciferol

Placebo DRUG

identical placebo pill orally by mouth

Also known as: D3

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85
• CKD stage 3-4 (GFR 15-59 ml/min/1.73 m2 body surface area, calculated by using the MDRD Study equation GFR Calculator)
• serum 25(OH)D concentrations ≤ 30 ng/mL, and serum PTH levels \>70 pg/mL documented within the last six months

You may not qualify if:

• History of liver failure (serum AST or ALT \> 3-fold the upper limit of normal)
• requiring dialysis at any stage of the study
• history of intestinal malabsorption or chronic diarrhea
• serum calcium level (corrected for serum albumin) \> 10.5 mg/dL
• calcium x phosphorus product \>70
• treatment with more than 1000 IU of vitamin D per day, or current treatment with a vitamin D analogue or calcimimetic
• an anti-epileptic medication and other medications which can affect vitamin D metabolism (e.g., phenobarbital, phenytoin, rifampicin)

Sponsors & Collaborators

• Atlanta VA Medical Center: lead

Study Sites (1)

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Related Publications (2)

• Chandra P, Binongo JN, Ziegler TR, Schlanger LE, Wang W, Someren JT, Tangpricha V. Cholecalciferol (vitamin D3) therapy and vitamin D insufficiency in patients with chronic kidney disease: a randomized controlled pilot study. Endocr Pract. 2008 Jan-Feb;14(1):10-7. doi: 10.4158/EP.14.1.10.

  PMID: 18238736 RESULT

• Alvarez JA, Law J, Coakley KE, Zughaier SM, Hao L, Shahid Salles K, Wasse H, Gutierrez OM, Ziegler TR, Tangpricha V. High-dose cholecalciferol reduces parathyroid hormone in patients with early chronic kidney disease: a pilot, randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2012 Sep;96(3):672-9. doi: 10.3945/ajcn.112.040642. Epub 2012 Aug 1.

  PMID: 22854402 DERIVED

Related Links

• Medscape Link

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Vitamin D Deficiency

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; 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

Results Point of Contact

• Title: Vin Tangpricha
• Organization: Emory University School of Medicine

vin.tangpricha@emory.edu

404-727-7254

Study Officials

• Vin Tangpricha, M.D. Ph.D.

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2007
• First Posted: January 26, 2007
• Study Start: December 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: March 1, 2013
• Last Updated: July 22, 2015
• Results First Posted: March 12, 2009

Record last verified: 2015-07

Locations

US (1)