Effects of DASH Diet on Corticosteroids Medication Use

Nutritional and Metabolic Disease Clinical Trial

Official title:

Phase 3 Study of Beneficiary Effects of Dietary Approaches to Stop Hypertension (DASH) on the Metabolic Aeffects of Corticosteroids Medications Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762267
• Other study ID #: DASH in corton therapy
• Status: Completed
• Phase: Phase 3
• First received: December 1, 2012
• Last updated: January 4, 2013
• Start date: January 2011
• Est. completion date: July 2012

Study information

• Verified date: January 2013
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 27 Years to 35 Years

Eligibility

Inclusion Criteria:

• patients who were on corticosteroid therapy

Exclusion Criteria:

• refuse to follow the visits

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Metabolic Diseases
• Nutritional and Metabolic Disease

Intervention

Other:
• nutrition intervention
DASH diet control diet

Locations

Country	Name	City	State
Iran, Islamic Republic of	1. Department of Community Nutrition, School of Nutrition & Food Science, Isfahan University of Medical Science	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	lipid profile (mg/dl), fasting blood glucose (mg/dl), blood pressure (mmHg), weight reduction (kg)		july	Yes
Primary	the amount of weight reduction and change of blood pressure	weight (kg) body mass index (kg/m2) blood pressure (mmHg)	up to 10 weeks	Yes
Secondary	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).	10 weeks	Yes