CClinicalTrials.gg
CompletedNCT00000511Updated Dec 13, 2013

Polyunsaturates and KCL to Control Mild Hypertension

A Phase 2 interventional study of mineral supplements and Trial 1: fatty acids, omega-3; Trial 2: Mineral supplements in Cardiovascular Diseases, Heart Diseases and Hypertension, sponsored by Brigham and Women's Hospital. Completed. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-12-13.

Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiovascular Diseases
  • Heart Diseases
  • Hypertension
  • Vascular Diseases
03

In context

Hypertension

6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.

Browse Hypertension studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Mild hypertensives, ages 21 to 70, with no evidence of end-organ damage.. Untreated hypertensives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment

Study arms

  • Placebo comparator
    Potassium, Magnesium, Calcium, The 3 together, Placebo

    Parallel study design, 4 treatment groups

    Dietary Supplement: mineral supplements · Dietary Supplement: Trial 1: fatty acids, omega-3; Trial 2: Mineral supplements · Behavioral: dietary supplements

Interventions

  • Dietary supplementmineral supplements
  • Dietary supplementTrial 1: fatty acids, omega-3; Trial 2: Mineral supplements
  • Behavioraldietary supplements
06

What researchers measure

Primary outcomes

  1. Blood Pressure

    14 hour ambulatory BP

    Time frame: End of study

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 8416666 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00000511
Lead sponsor
Brigham and Women's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Frank M. Sacks (Professor of Medicine, Brigham and Women's Hospital) — Principal investigator
First posted
Oct 28, 1999
Start date
Dec 1983
Primary completion
Nov 1994
Completion
Nov 1994
Last update
Dec 13, 2013
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion