NCT01596842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 11, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

March 10, 2015

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

May 8, 2012

Results QC Date

February 20, 2015

Last Update Submit

March 8, 2015

Conditions

Hemodialysis PatientsVitamin D InsufficiencyVitamin D Deficiency

Keywords

Omega-3 fatty acidvitamin Dergocalciferolhemodialysis

Outcome Measures

Primary Outcomes (1)

  • 25-hydroxyvitamin D Levels at 12 Weeks

    12 weeks

Secondary Outcomes (8)

  • Hemoglobin Levels at 12 Weeks

    12 weeks

  • Changes of Calcium Levels

    4 weeks, 8 weeks and 12 weeks

  • Change of Intact Parathyroid Hormone

    12 weeks

  • Change of Fetuin-A Levels

    12 weeks

  • Change of FGF-23 Levels

    12 weeks

  • +3 more secondary outcomes

Study Arms (2)

Omega-3 fatty acid

ACTIVE COMPARATOR
Drug: Omega-3 fatty acid ethylester 90Other: cholecalciferol

Olive oil

PLACEBO COMPARATOR
Other: Olive oilOther: cholecalciferol

Interventions

Omega-3 fatty acid ethylester 90DRUG

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

Also known as: Omacor®
Omega-3 fatty acid
Olive oilOTHER

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

Olive oil
cholecalciferolOTHER

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

Olive oilOmega-3 fatty acid

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Won Suk An

Busan, 602-715, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 25636157DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

OmacorOlive OilCholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane Lipids

Results Point of Contact

Title
Professor
Organization
Dong-A University
anws@dau.ac.kr
82-51-240-2811

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 8, 2012

First Posted

May 11, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 10, 2015

Results First Posted

March 10, 2015

Record last verified: 2015-03

Locations

KR(1)