Effect of Omega-3 Fatty Acid on Vitamin D Activation

March 8, 2015 updated by: WON SUK AN, Dong-A University

Effect of Omega-3 Fatty Acid on Vitamin D Activation in Hemodialysis Patients

Extra-renal sources of 1, 25-dihydroxyvitamin D can be increased to normal serum 1, 25-dihydroxyvitamin D levels in chronic kidney disease patients after administration of high dose 25-hydroxyvitamin D. The investigators observed that 1, 25-dihydroxyvitamin D concentrations were significantly increased after 3 months of omega-3 FA supplementation compared to baseline levels without 25-hydroxyvitamin D administration in dialysis patients. In this study, the investigators hypothesized that omega-3 FA and 25-hydroxyvitamin D supplementations may increase 1, 25-dihydroxyvitamin D concentrations much more compared to 25-hydroxyvitamin D supplementation only in hemodialysis patients with insufficient or deficient 25-hydroxyvitamin D levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who were treated with hemodialysis for at least 6 months with 25-hydroxyvitamin D < 30 ng/mL

Exclusion Criteria:

  • Patients with a history of active infection within 3 months,
  • Patients with fish oil or omega-3 fatty acid supplementation within 3 months,
  • Patients with a history of fish, gelatin, and/or omega-3 fatty acid allergies,
  • Patients with a history of hospital admission within 3 months,
  • Patients with a history of bleeding within 3 months,
  • Patients with thrombocytopenia,
  • Patients with current use of warfarin,
  • Patients with an albumin level < 3.0 g/dL,
  • Patients with malignancy and/or liver cirrhosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Olive oil
Other: cholecalciferol
if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks
Other: Olive oil
Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks
Active Comparator: Omega-3 fatty acid
Drug: Omega-3 fatty acid ethylester 90
Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks
Other Names:
  • Omacor®
Other: cholecalciferol
if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
25-hydroxyvitamin D Levels at 12 Weeks
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Hemoglobin Levels at 12 Weeks
Time Frame: 12 weeks
12 weeks
Changes of Calcium Levels
Time Frame: 4 weeks, 8 weeks and 12 weeks
4 weeks, 8 weeks and 12 weeks
Change of Intact Parathyroid Hormone
Time Frame: 12 weeks
12 weeks
Change of Fetuin-A Levels
Time Frame: 12 weeks
12 weeks
Change of FGF-23 Levels
Time Frame: 12 weeks
12 weeks
Changes of Phosphorous Levels
Time Frame: 4 weeks, 8 weeks and 12 weeks
4 weeks, 8 weeks and 12 weeks
Changes of Erythropoietin Doses
Time Frame: 4 weeks, 8 weeks and 12 weeks
4 weeks, 8 weeks and 12 weeks
Changes of Phosphate Binder Doses
Time Frame: 4 weeks, 8 weeks and 12 weeks
4 weeks, 8 weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

May 8, 2012

First Submitted That Met QC Criteria

May 9, 2012

First Posted (Estimate)

May 11, 2012

Study Record Updates

Last Update Posted (Estimate)

March 10, 2015

Last Update Submitted That Met QC Criteria

March 8, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAU-12-073

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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