NCT00817622

Brief Summary

The purpose of this study is to evaluate efficacy and safety of EPA(Eicosapentaenoic Acid)alone and with VitE in diabetic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for phase_4 diabetes-mellitus

Timeline
Completed

Started Jan 2007

Typical duration for phase_4 diabetes-mellitus

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

January 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

November 18, 2009

Status Verified

November 1, 2009

Enrollment Period

2.4 years

First QC Date

January 3, 2009

Last Update Submit

November 17, 2009

Conditions

Diabetes Mellitus

Keywords

diabetes mellitus type 2EPAleptinadiponectin

Outcome Measures

Primary Outcomes (1)

  • Changes in leptin and adiponectin after 12 Weeks

    12 weeks

Study Arms (4)

A

PLACEBO COMPARATOR

Placebo, Placebo : Placebo pearls,500 mg QID for 12 Weeks (2000 mg corn oil per day) Placebo pearl + corn oil 400 mg per day for 12 weeks

Dietary Supplement: EPA, Vitamin E

B

ACTIVE COMPARATOR

EPA, Placebo : EPA pearls,500 mg QID for 12 Weeks (2000 mg per day),From MINAMINUTRITION Company(Belgium)+ Placebo pearl ,corn oil 400 mg per day for 12 weeks

Dietary Supplement: EPA, Vitamin E

C

PLACEBO COMPARATOR

Placebo ,Vitamin E : Placebo pearls,500 mg QID for 12 Weeks (2000 mg corn oil per day)+ Vitamin E pearls, 400 mg from DANA Company(IRAN) per day for 12 weeks

Dietary Supplement: EPA, Vitamin E

D

ACTIVE COMPARATOR

EPA, Vitamin E : EPA pearls,500 mg QID From MINAMINUTRITION Company(Belgium) for 12 Weeks (2000 mg EPA per day)+ Vitamin E pearls, 400 mg from DANA Company ( IRAN) per day for 12 weeks

Dietary Supplement: EPA, Vitamin E

Interventions

EPA, Vitamin EDIETARY_SUPPLEMENT

EPA pearls, 500 mg QID for 12 Weeks (2000 mg per day) Vitamin E pearls, 400 mg per day for 12 weeks

Also known as: Plus EPA
ABCD

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • DM Type II.
  • Antidiabetic drug therapy which cannot be stopped.
  • History of DM about 2-15 year.
  • Age between 30-55 year.
  • No History of circulatory, thyroid, pulmonary, liver, kidney, cancer.

You may not qualify if:

  • DM Type I.
  • Nephropathy.
  • Retinopathy.
  • Cancer.
  • Thyroid disease.
  • Renal failure.
  • pulmonary disease
  • MI.
  • CHD.
  • Liver disease,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran University Of Medical Sciences

Tehran, Tehran Province, Iran

Location

Related Publications (1)

  • Sarbolouki Sh, Djalali M, Dorosty A, Djazayery S, Eshraghian M, Ebadi S, Hashemi S. Effects of EPA and Vitamin E on Serum Enzymatic Antioxidants and Peroxidation Indices in Patients with Type II Diabetes Mellitus. Iran J Public Health. 2010;39(3):82-91. Epub 2010 Sep 30.

    PMID: 23113026DERIVED

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Mahmood Djalali, Professor

    Tehran University of Medical Sciences, school of Public Health

    STUDY CHAIR

  • Shokooh Sarbolouki, PhD Student

    Tehran University of Medical Sciences, School of Public Health

    PRINCIPAL INVESTIGATOR

  • Ahmad Reza - Dorosti, Ph.D.

    Tehran University of Medical Sciences,School of Public Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2009

First Posted

January 6, 2009

Study Start

January 1, 2007

Primary Completion

June 1, 2009

Study Completion

September 1, 2009

Last Updated

November 18, 2009

Record last verified: 2009-11

Locations

IR(1)