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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
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 27, 1999
    Last Updated
    December 12, 2013
    Sponsor
    Brigham and Women's Hospital
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    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.
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    Learn more about this trial

    Polyunsaturates and KCL to Control Mild Hypertension

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