Dietary Intervention Study for Hypertension (DISH)

• ClinicalTrials.gov Identifier: NCT00000497
• Recruitment Status: Completed
• First Posted: October 28, 1999
• Last Update Posted: April 15, 2015
• Sponsor: University of Mississippi Medical Center
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by: University of Mississippi Medical Center

Tracking Information

• First Submitted Date: October 27, 1999
• First Posted Date: October 28, 1999
• Last Update Posted Date: April 15, 2015
• Study Start Date: January 1980
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dietary Intervention Study for Hypertension (DISH)
• Official Title: Not Provided
• 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enable drug controlled hypertensive patients to remain at 'goal blood pressures' after antihypertensive medication was withdrawn.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.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Primary Purpose: Treatment

Condition

• Cardiovascular Diseases
• Heart Diseases
• Hypertension
• Vascular Diseases

Intervention

• Behavioral: diet, sodium-restricted
• Behavioral: diet, reducing

• Study Arms: Not Provided

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• Langford HG, Schlundt D, Levine K. Sodium restriction in hypertension. Compr Ther. 1984 Sep;10(9):6-11.

Recruitment Information

• Recruitment Status: Completed
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Actual Study Completion Date: September 1994
• Primary Completion Date: Not Provided
• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00000497
• Other Study ID Numbers: 16; U01HL037854 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Mississippi Medical Center
• Original Study Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Investigator: Herbert Langford; University of Mississippi Medical Center

• PRS Account: University of Mississippi Medical Center
• Verification Date: January 2000