NCT02117960

Brief Summary

The aim of this study is the comparison between the effects of supplementation with omega 3 or placebo for 8 weeks in serum level of BMP-4, YKL40, HSP70, HSP27 in patients with cardiovascular disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2011

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

December 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

1.7 years

First QC Date

April 16, 2014

Last Update Submit

April 7, 2015

Conditions

Cardiovascular Disease

Keywords

atheroscleroticBMP-4YKL40HSP70HSP27

Outcome Measures

Primary Outcomes (1)

  • Serum Heat Shock Protein 70(HSP70)

    Change frome baseline at 2 months

Secondary Outcomes (5)

  • Serum Ox-LDL

    Change frome baseline at 2 months

  • Serum BMP4 (Bone Morphogenic Protein4)

    Change frome baseline at 2 months

  • Serum Heat Shock Protein 27(HSP27)

    Change frome baseline at 2 months

  • Serum YKL40

    Change frome baseline at 2 months

  • Serum hsCRP

    Change frome baseline at 2 months

Study Arms (2)

CVD, Omega-3

ACTIVE COMPARATOR

patients with Cardiovascular disease who receive 4g/d omega-3

Dietary Supplement: Omega-3

CVD, Placebo

PLACEBO COMPARATOR

patients with cardiovascular disease who receive 4 cap of placebo/day

Dietary Supplement: Placebo

Interventions

Omega-3DIETARY_SUPPLEMENT

4 cap 1 g Omega-3 per day for 2 months

Also known as: n-3 fatty acids, n-3 PUFA
CVD, Omega-3
PlaceboDIETARY_SUPPLEMENT

4 cap 1 g Placebo(paraffin) per day for 2 months

CVD, Placebo

Eligibility Criteria

Age45 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CVD patients 45- 65 years old, patients with ≥ 50% stenosis in at least one coronary angiogram demonstrated, body mass index in the range 18.5- 35, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention, willingness to participation,

You may not qualify if:

  • people who have used omega 3 supplements in last 3 months, having chronic renal disease , GI disease, hepatobiliary diseases, hematological disorders, hypo- or hyperthyroidism, Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran University of Medical Sciences

Tehran, Iran

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Docosahexaenoic AcidsFatty Acids, Omega-3

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Mahmoud Jalali, Ph.D

    Department of Nutrition & Biochemistry, School of Public Health, Tehran University of Medical Sciences (TUMS)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2014

First Posted

April 21, 2014

Study Start

December 1, 2011

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

IR(1)