NCT03465462

The Influence of Hypotensive Drugs on Mineral Status in Experimental and Clinical Studies

The Influence of Hypotensive Drugs on Zinc, Copper and Iron Status in Experimental and Clinical Studies.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Poznan University of Life Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of the study was to evaluate the effects of hypotensive treatment combined with a higher zinc supply in the diet and supplements on the mineral status and selected biochemical parameters of newly diagnosed hypertensive patients on monotherapy.

Detailed description

The study was designed as a prospective randomized trial and was performed in three stages. In the first stage, primary hypertension was diagnosed and antihypertensive monotherapy was implemented. In the second stage, patients underwent antihypertensive monotherapy lasting three months. The subjects received diuretics; calcium antagonists (Ca-antagonists); angiotensin-converting-enzyme inhibitors (ACE-Is); angiotensin II receptor antagonists (ARBs); or β-blockers. After three months of monotherapy, patients were divided using a randomization list into three equal groups: C (control group), D (diet group) and S (supplementation group). In the third stage, which lasted 30 days, subjects from all groups received the same antihypertensive drug as in the second stage and either an optimal-mineral-content diet (group D), zinc supplementation (group S), or continued drug use with no change in diet and no mineral supplementation (group C). Patients from group D received an optimal-mineral-content properly balanced diet enriched in food with high zinc content prepared individually for each patient by a qualified dietician. Patients from group S received zinc supplementation as one capsule containing 15 mg of Zn taken orally once a day in the morning, two hours after antihypertensive drug administration with no change in diet, through all 30 days of the third stage of the trial. During the study, patients were asked to not use dietary supplements and not to change their lifestyle or level of physical activity. On the last day of each stage of the study, blood, urine, and hair samples were collected from the subjects, and blood pressure and anthropometric parameters were measured.

Conditions

• Nutritional Disorder
• Hypertension
• Mineral Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	group/arm C (control group)	Group C in the third stage (30 days) continued drug use with no change in diet and no mineral supplementation.
DIETARY_SUPPLEMENT	group/arm D (diet group)	Group D in the third stage (30 days) received an optimal-mineral-content properly balanced diet enriched in food with high zinc content.
DIETARY_SUPPLEMENT	group/arm S (supplementation group)	Group S in the third stage (30 days) received zinc supplementation as one capsule containing 15 mg of Zn taken orally once a day in the morning, two hours after antihypertensive drug administration with no change in diet.

Timeline

• Start date: 2016-01-02
• Primary completion: 2016-12-29
• Completion: 2016-12-30
• First posted: 2018-03-14
• Last updated: 2018-03-14

Locations

1 site across 1 country: Poland