NCT01762267

Brief Summary

To determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on the metabolic side effects of corticosteroids medications use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 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

January 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 7, 2013

Completed
Last Updated

January 7, 2013

Status Verified

January 1, 2013

Enrollment Period

1.4 years

First QC Date

December 1, 2012

Last Update Submit

January 4, 2013

Conditions

Nutritional and Metabolic Disease

Outcome Measures

Primary Outcomes (1)

  • the amount of weight reduction and change of blood pressure

    weight (kg) body mass index (kg/m2) blood pressure (mmHg)

    up to 10 weeks

Secondary Outcomes (1)

  • lipid profile, fasting blood glucose

    10 weeks

Other Outcomes (1)

  • lipid profile (mg/dl), fasting blood glucose (mg/dl), blood pressure (mmHg), weight reduction (kg)

    july

Study Arms (2)

diet intervention, DASH diet

ACTIVE COMPARATOR

intervention: nutrition intervention: DASH diet

Other: nutrition intervention

not intervention, control diet

NO INTERVENTION

control weight loss diet

Interventions

nutrition interventionOTHER

DASH diet control diet

diet intervention, DASH diet

Eligibility Criteria

Age27 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients who were on corticosteroid therapy

You may not qualify if:

  • refuse to follow the visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1. Department of Community Nutrition, School of Nutrition & Food Science, Isfahan University of Medical Science

Isfahan, Iran

Location

MeSH Terms

Conditions

Metabolic Diseases

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Leila azadbakht, PhD

    1. Department of Community Nutrition, School of Nutrition & Food Science, Isfahan University of Medical Science, Isfahan, Iran

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Isfahan University of Medical Sciences

Study Record Dates

First Submitted

December 1, 2012

First Posted

January 7, 2013

Study Start

January 1, 2011

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

January 7, 2013

Record last verified: 2013-01

Locations

IR(1)