NCT00000511

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 1983

Longer than P75 for phase_2 cardiovascular-diseases

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1983

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 1994

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 1994

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

December 13, 2013

Status Verified

December 1, 2013

Enrollment Period

10.9 years

First QC Date

October 27, 1999

Last Update Submit

December 12, 2013

Conditions

Cardiovascular DiseasesHeart DiseasesHypertensionVascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

    14 hour ambulatory BP

    End of study

Study Arms (1)

Potassium, Magnesium, Calcium, The 3 together, Placebo

PLACEBO COMPARATOR

Parallel study design, 4 treatment groups

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

Interventions

mineral supplementsDIETARY_SUPPLEMENT
Potassium, Magnesium, Calcium, The 3 together, Placebo
Trial 1: fatty acids, omega-3; Trial 2: Mineral supplementsDIETARY_SUPPLEMENT
Potassium, Magnesium, Calcium, The 3 together, Placebo
dietary supplementsBEHAVIORAL
Potassium, Magnesium, Calcium, The 3 together, Placebo

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Mild hypertensives, ages 21 to 70, with no evidence of end-organ damage.. Untreated hypertensives.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 8416666BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesHypertensionVascular Diseases

Interventions

Docosahexaenoic AcidsDietary Supplements

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

December 1, 1983

Primary Completion

November 1, 1994

Study Completion

November 1, 1994

Last Updated

December 13, 2013

Record last verified: 2013-12