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Effects of DASH Diet on Corticosteroids Medication Use

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leila Azadbakht, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01762267
First received: December 1, 2012
Last updated: January 4, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Nutritional and Metabolic Disease
 Other: nutrition intervention
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Phase 3 Study of Beneficiary Effects of Dietary Approaches to Stop Hypertension (DASH) on the Metabolic Aeffects of Corticosteroids Medications Use

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • the amount of weight reduction and change of blood pressure [ Time Frame: up to 10 weeks ] [ Designated as safety issue: Yes ]
    weight (kg) body mass index (kg/m2) blood pressure (mmHg)


Secondary Outcome Measures:
  • lipid profile, fasting blood glucose [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
    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).


Other Outcome Measures:
  • lipid profile (mg/dl), fasting blood glucose (mg/dl), blood pressure (mmHg), weight reduction (kg) [ Time Frame: july ] [ Designated as safety issue: Yes ]

Enrollment: 62
Study Start Date: January 2011
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: diet intervention, DASH diet
intervention: nutrition intervention: DASH diet
 Other: nutrition intervention
DASH diet control diet
No Intervention: not intervention, control diet
control weight loss diet

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.

  Eligibility

Ages Eligible for Study:   27 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients who were on corticosteroid therapy

Exclusion Criteria:

  • refuse to follow the visits
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01762267

Locations
Iran, Islamic Republic of
1. Department of Community Nutrition, School of Nutrition & Food Science, Isfahan University of Medical Science
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Study Director: Leila azadbakht, PhD 1. Department of Community Nutrition, School of Nutrition & Food Science, Isfahan University of Medical Science, Isfahan, Iran
  More Information

No publications provided

Responsible Party: Leila Azadbakht, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01762267     History of Changes
Other Study ID Numbers: DASH in corton therapy
Study First Received: December 1, 2012
Last Updated: January 4, 2013
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Metabolic Diseases

ClinicalTrials.gov processed this record on May 22, 2013