Dietary Intervention Study for Hypertension (DISH)
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Hypertension
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
diet, sodium-restricted
diet, reducing
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Diseases
Eligibility Criteria
Men and women with hypertension. Diastolic blood pressure equal to or above 95 mm Hg and 90 mm Hg, respectively for home and clinic readings.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000497
First Posted
October 27, 1999
Last Updated
April 14, 2015
Sponsor
University of Mississippi Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00000497
Brief Title
Dietary Intervention Study for Hypertension (DISH)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2000
Overall Recruitment Status
Completed
Study Start Date
January 1980 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 1994 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Mississippi Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
The primary objective of this multicenter cooperative clinical trial was to determine if dietary modification would enable drug controlled hypertensive patients to remain at 'goal blood pressures' after antihypertensive medication was withdrawn. The proposal made use of the HDFP hypertensive population who had five years of treatment for their hypertension. Additionally, the group of investigators proposed to determine if dietary treatment would permit patients not previously adequately controlled under the HDFP program to achieve normalization of blood pressure with a combination of dietary modification and drug treatment. The study also proposed to search for predictors (i.e., levels of hormonal agents such as plasma renin activity) of responsiveness to dietary manipulation among the hypertensive population as well as to identify psychological attributes that might be of importance in managing these patients.
Detailed Description
BACKGROUND:
The background against which the proposal was made had been developed from the combined information of the Veterans Administration Cooperative Study and the Hypertension Detection and Follow-up Study. Data from both these studies clearly established the importance of reducing sodium content by means of diuretic administration as a mainstay of the treatment of elevated blood pressure. The risks of the lifetime of treatment were undefined, but the cost of indefinite treatment of high blood pressure was sufficiently high to stimulate careful examination of alternative modes of management of such patients. The demonstrations by Parijs and others that moderate reduction in sodium intake led to improved management of hypertension and data suggesting that increased potassium intake may enhance this blood pressure lowering effect associated with sodium restriction was cited by the investigators as a basis for the trial. Any additional data regarding modest sodium restriction and potassium ingestion would have impact on utilizing such therapy in preventing hypertension and as adjunctive therapy.
DESIGN NARRATIVE:
The study was intended to take advantage of the availability of patients at the three centers at the completion of the Hypertension Detection and Follow-up Program Study. These patients were enrolled as 'stepped-care' participants and had been treated with antihypertensive drugs for at least five years. The main objective of the study was to determine the contribution of dietary modification to maintenance of normal blood pressure after withdrawal of medication. Two types of diet change were followed: 1) reduction of sodium intake coupled with increased potassium intake; and 2) reduction of weight in the subgroups of patients that were obese.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Hypertension, Vascular Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
diet, sodium-restricted
Intervention Type
Behavioral
Intervention Name(s)
diet, reducing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Men and women with hypertension. Diastolic blood pressure equal to or above 95 mm Hg and 90 mm Hg, respectively for home and clinic readings.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert Langford
Organizational Affiliation
University of Mississippi Medical Center
12. IPD Sharing Statement
Citations:
Citation
Wassertheil-Smoller S, Langford HG, Blaufox, MD, et al: Rate of Hypertension Return After Withdrawal of Prolonged Antihypertensive Therapy. Clin Sci, 63: 423S-525S (Supp 8), 1982.
Results Reference
background
PubMed Identifier
6342972
Citation
Wassertheil-Smoller, Langford HG, Blaufox MD, Oberman A, Hawkins M. Diuretics and salt restriction in blood pressure control. Curr Concepts Nutr. 1983;12:175-89. No abstract available.
Results Reference
background
Citation
Langford HG, Blaufox, MD, Oberman A, et al: Effect of Weight Loss on the Return of Hypertension After Withdrawal of Prolonged Antihypertensive Therapy. Nutritional Prevention of Cardiovascular Disease, 301-315, 1984.
Results Reference
background
PubMed Identifier
6494106
Citation
Wing RR, Caggiula AW, Nowalk MP, Koeske R, Lee S, Langford H. Dietary approaches to the reduction of blood pressure: the independence of weight and sodium/potassium interventions. Prev Med. 1984 May;13(3):233-44. doi: 10.1016/0091-7435(84)90081-1.
Results Reference
background
PubMed Identifier
3881608
Citation
Langford HG, Blaufox MD, Oberman A, Hawkins CM, Curb JD, Cutter GR, Wassertheil-Smoller S, Pressel S, Babcock C, Abernethy JD, et al. Dietary therapy slows the return of hypertension after stopping prolonged medication. JAMA. 1985 Feb 1;253(5):657-64.
Results Reference
background
PubMed Identifier
6488753
Citation
Langford HG, Schlundt D, Levine K. Sodium restriction in hypertension. Compr Ther. 1984 Sep;10(9):6-11.
Results Reference
background
Learn more about this trial
Dietary Intervention Study for Hypertension (DISH)
We'll reach out to this number within 24 hrs