Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000511
Status:
COMPLETED
Last Update Posted:
2013-12-13
First Post:
1999-10-27
Brief Title:
Polyunsaturates and KCL to Control Mild Hypertension
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 gramsday 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 QueryViewReport QVR System
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 gramsday 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 QueryViewReport QVR System
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL034593-05 | NIH | None | httpsreporternihgovquickSearchR01HL034593-05 |
| R01HL034593 | NIH | None | None |