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Effect of Omega-3 Fatty Acid on Vitamin D Activation

Primary Purpose

Hemodialysis Patients, Vitamin D Insufficiency, Vitamin D Deficiency

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Omega-3 fatty acid ethylester 90

Olive oil

cholecalciferol

About this trial

This is an interventional treatment trial for Hemodialysis Patients focused on measuring Omega-3 fatty acid, vitamin D, ergocalciferol, hemodialysis

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Won Suk An

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Omega-3 fatty acid

Olive oil

Arm Description

Outcomes

Primary Outcome Measures

25-hydroxyvitamin D Levels at 12 Weeks

Secondary Outcome Measures

Hemoglobin Levels at 12 Weeks

Changes of Calcium Levels

Change of Intact Parathyroid Hormone

Change of Fetuin-A Levels

Change of FGF-23 Levels

Changes of Phosphorous Levels

Changes of Erythropoietin Doses

Changes of Phosphate Binder Doses

Full Information

NCT ID

NCT01596842

First Posted

May 8, 2012

Last Updated

March 8, 2015

Sponsor

Dong-A University

1. Study Identification

Unique Protocol Identification Number

NCT01596842

Brief Title

Effect of Omega-3 Fatty Acid on Vitamin D Activation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dong-A University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemodialysis Patients, Vitamin D Insufficiency, Vitamin D Deficiency

Keywords

Omega-3 fatty acid, vitamin D, ergocalciferol, hemodialysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Omega-3 fatty acid

Arm Type

Active Comparator

Arm Title

Olive oil

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Omega-3 fatty acid ethylester 90

Other Intervention Name(s)

Omacor®

Intervention Description

Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks

Intervention Type

Other

Intervention Name(s)

Olive oil

Intervention Description

Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks

Intervention Type

Other

Intervention Name(s)

cholecalciferol

Intervention Description

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

Primary Outcome Measure Information:

Title

25-hydroxyvitamin D Levels at 12 Weeks

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Hemoglobin Levels at 12 Weeks

Time Frame

12 weeks

Title

Changes of Calcium Levels

Time Frame

4 weeks, 8 weeks and 12 weeks

Title

Change of Intact Parathyroid Hormone

Time Frame

12 weeks

Title

Change of Fetuin-A Levels

Time Frame

12 weeks

Title

Change of FGF-23 Levels

Time Frame

12 weeks

Title

Changes of Phosphorous Levels

Time Frame

4 weeks, 8 weeks and 12 weeks

Title

Changes of Erythropoietin Doses

Time Frame

4 weeks, 8 weeks and 12 weeks

Title

Changes of Phosphate Binder Doses

Time Frame

4 weeks, 8 weeks and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Won Suk An

City

Busan

ZIP/Postal Code

602-715

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

25636157

Citation

Lee SM, Son YK, Kim SE, An WS. The effects of omega-3 fatty acid on vitamin D activation in hemodialysis patients: a pilot study. Mar Drugs. 2015 Jan 28;13(2):741-55. doi: 10.3390/md13020741.

Results Reference

derived

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Effect of Omega-3 Fatty Acid on Vitamin D Activation

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