Polyunsaturates and KCL to Control Mild Hypertension
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Hypertension
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
mineral supplements
Trial 1: fatty acids, omega-3; Trial 2: Mineral supplements
dietary supplements
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Diseases
Eligibility Criteria
Mild hypertensives, ages 21 to 70, with no evidence of end-organ damage.. Untreated hypertensives.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
Potassium, Magnesium, Calcium, The 3 together, Placebo
Arm Description
Parallel study design, 4 treatment groups
Outcomes
Primary Outcome Measures
Blood Pressure
14 hour ambulatory BP
Secondary Outcome Measures
Full Information
NCT ID
NCT00000511
First Posted
October 27, 1999
Last Updated
December 12, 2013
Sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00000511
Brief Title
Polyunsaturates and KCL to Control Mild Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
December 1983 (undefined)
Primary Completion Date
November 1994 (Actual)
Study Completion Date
November 1994 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To test the efficacy of omega-3 fatty acids in untreated mild hypertensives and magnesium, calcium, and potassium supplementation supplementation in non-hypertensives. These clinical trials were conducted in sequence over a four year period.
Detailed Description
BACKGROUND:
The hypothesis that omega-3 fatty acids as well as magnesium and potassium in the diet lowered blood pressure in mild hypertensives needed further documentation, although preliminary and less well controlled studies had suggested such an effect was possible. In a previous study the investigators did not find a hypotensive effect of another polyunsaturated fatty acid, linoleic acid. In addition, findings of lower blood pressures in vegetarians and results obtained from a study in which vegetarian diets were fed to normotensives led to the conclusion that dietary factors other then linoleic acid were responsible for the possible hypotensive effect of vegetarian diets. The nutrients which were selected for further study, omega-3 fatty acids, magnesium and potassium, occur in higher amounts in vegetarian diets.
Dietary supplementation with fish oils had only been done in a few studies with inconclusive results. However, the relationship of omega-3 fatty acids to the synthesis of prostacyclins, which are locally active vasodilators and which decrease with the excretion of the vasoconstrictor thromboxane, provide a possible mechanism for an effect of these compounds on blood pressure.
The role of potassium in the control of blood pressure was first suggested from cross-cultural studies in which populations consuming high levels of potassium displayed lower rates of hypertension and a decrease in blood pressure with age. Cohort studies within this country have also shown a relationship between potassium intake or the ratio of potassium and sodium, as measured by urinary excretion and blood pressure. Most constantly it found that blood pressure differences between blacks and whites have been related to differences in potassium excretion.
The results from human experimental studies involving potassium supplementation in normotensives and hypertensives have indicated mixed effects but blood pressure lowering was most consistently observed in subgroups with a family history of hypertension or those with higher blood pressure.
DESIGN NARRATIVE:
Trial 1: Subjects were randomized to a fish oil treatment group of 6 or 12 grams/day of omega-3 fatty acids or to a placebo group. At the end of 12 and 24 weeks, participants in the three groups were crossed-over to one of the other two treatments for an additional 12 weeks. The primary outcome was clinic blood pressure on 3 days at the end of the treatment period.
Trial 2: Subjects were randomly assigned to one of four treatments and placebo: magnesium supplementation; potassium supplementation; calcium supplementation; all 3 supplements; matching placebos. The trial was double-blinded. Each of the treatments was administered for six months with measurements taken at baseline and at the end. The primary outcome was 24-hour ambulatory systolic BP.
The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.
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 2
Interventional Study Model
Crossover Assignment
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
Potassium, Magnesium, Calcium, The 3 together, Placebo
Arm Type
Placebo Comparator
Arm Description
Parallel study design, 4 treatment groups
Intervention Type
Dietary Supplement
Intervention Name(s)
mineral supplements
Intervention Type
Dietary Supplement
Intervention Name(s)
Trial 1: fatty acids, omega-3; Trial 2: Mineral supplements
Intervention Type
Behavioral
Intervention Name(s)
dietary supplements
Primary Outcome Measure Information:
Title
Blood Pressure
Description
14 hour ambulatory BP
Time Frame
End of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Mild hypertensives, ages 21 to 70, with no evidence of end-organ damage.. Untreated hypertensives.
12. IPD Sharing Statement
Citations:
PubMed Identifier
8416666
Citation
Morris MC, Taylor JO, Stampfer MJ, Rosner B, Sacks FM. The effect of fish oil on blood pressure in mild hypertensive subjects: a randomized crossover trial. Am J Clin Nutr. 1993 Jan;57(1):59-64. doi: 10.1093/ajcn/57.1.59.
Results Reference
background
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Polyunsaturates and KCL to Control Mild Hypertension
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