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Effects of DASH Diet on Corticosteroids Medication Use

Primary Purpose

Nutritional and Metabolic Disease

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
nutrition intervention
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Nutritional and Metabolic Disease

Eligibility Criteria

27 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • patients who were on corticosteroid therapy

Exclusion Criteria:

  • refuse to follow the visits

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

diet intervention, DASH diet

not intervention, control diet

Arm Description

intervention: nutrition intervention: DASH diet

control weight loss diet

Outcomes

Primary Outcome Measures

the amount of weight reduction and change of blood pressure
weight (kg) body mass index (kg/m2) blood pressure (mmHg)

Secondary Outcome Measures

lipid profile, fasting blood glucose
measurement of LDL-C (mg/dl), HDL-C (mg/dl), triglyceride (mg/dl), total cholesterol (mg/dl), fasting blood glucose(mg/dl), by the analysis of blood samples and blood pressure(mmHg) and weight (kg), waist circumference (cm), body mass index (kg/m2).

Full Information

First Posted
December 1, 2012
Last Updated
January 4, 2013
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01762267
Brief Title
Effects of DASH Diet on Corticosteroids Medication Use
Official Title
Phase 3 Study of Beneficiary Effects of Dietary Approaches to Stop Hypertension (DASH) on the Metabolic Aeffects of Corticosteroids Medications Use
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on the metabolic side effects of corticosteroids medications use.
Detailed Description
Objective: To determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on the metabolic side effects of corticosteroids medications use. Design: A randomized clinical trial was undertaken in 60 patients on corticosteroid therapy for 10 weeks. Patients were randomly assigned to a DASH or control diet. Fasting blood sample were measured to determine blood glucose and lipid profile. Blood pressure and anthropometric measurements were measured based on the standard guidelines.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
diet intervention, DASH diet
Arm Type
Active Comparator
Arm Description
intervention: nutrition intervention: DASH diet
Arm Title
not intervention, control diet
Arm Type
No Intervention
Arm Description
control weight loss diet
Intervention Type
Other
Intervention Name(s)
nutrition intervention
Intervention Description
DASH diet control diet
Primary Outcome Measure Information:
Title
the amount of weight reduction and change of blood pressure
Description
weight (kg) body mass index (kg/m2) blood pressure (mmHg)
Time Frame
up to 10 weeks
Secondary Outcome Measure Information:
Title
lipid profile, fasting blood glucose
Description
measurement of LDL-C (mg/dl), HDL-C (mg/dl), triglyceride (mg/dl), total cholesterol (mg/dl), fasting blood glucose(mg/dl), by the analysis of blood samples and blood pressure(mmHg) and weight (kg), waist circumference (cm), body mass index (kg/m2).
Time Frame
10 weeks
Other Pre-specified Outcome Measures:
Title
lipid profile (mg/dl), fasting blood glucose (mg/dl), blood pressure (mmHg), weight reduction (kg)
Time Frame
july

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
27 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients who were on corticosteroid therapy Exclusion Criteria: refuse to follow the visits
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leila azadbakht, PhD
Organizational Affiliation
1. Department of Community Nutrition, School of Nutrition & Food Science, Isfahan University of Medical Science, Isfahan, Iran
Official's Role
Study Director
Facility Information:
Facility Name
1. Department of Community Nutrition, School of Nutrition & Food Science, Isfahan University of Medical Science
City
Isfahan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Effects of DASH Diet on Corticosteroids Medication Use

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