Effects of DASH Diet on Corticosteroids Medication Use | NCT01762267

Studies
Effects of DASH Diet on Corticosteroids Medication Use

NCT01762267

Sponsor

Isfahan University of Medical Sciences

Status

Completed

Last Update Posted

Jan 7, 2013Estimated

Enrollment

62Actual

Phase

Phase 3

Conditions

Nutritional and Metabolic Disease

Interventions

nutrition intervention

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jun 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Dec 1, 2012

First Submission Date that Met QC Criteria

Jan 4, 2013

First Posted Date

Jan 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2013

Last Update Posted Date

Jan 7, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leila Azadbakht, Isfahan University of Medical Sciences, Isfahan University of Medical SciencesPrincipal Investigator

Lead Sponsor

Isfahan University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
nutrition intervention	Other	DASH diet control diet	diet intervention, DASH diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Measure	Description	Time Frame
lipid profile (mg/dl), fasting blood glucose (mg/dl), blood pressure (mmHg), weight reduction (kg)		july

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients who were on corticosteroid therapy

Exclusion Criteria:

refuse to follow the visits

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

27 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leila azadbakht, PhD	1. Department of Community Nutrition, School of Nutrition & Food Science, Isfahan University of Medical Science, Isfahan, Iran	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
1. Department of Community Nutrition, School of Nutrition & Food Science, Isfahan University of Medical Science		Isfahan			Iran

Condition Browse Module

MeSH Terms

ID	Term
D008659	Metabolic Diseases

Ancestor Terms

ID	Term
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004035	Diet Therapy

Ancestor Terms

ID	Term
D044623	Nutrition Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided