Poznan University of Life Sciences
Poznan, 60-624, Poland
NCT Number: NCT03465462
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Poznan, 60-624, Poland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Group C in the third stage (30 days) continued drug use with no change in diet and no mineral supplementation.
Group D in the third stage (30 days) received an optimal-mineral-content properly balanced diet enriched in food with high zinc content.
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.
Time frame: At baseline
Serum zinc concentration in stage I of the trial
Time frame: After 3 months
Serum zinc concentration in stage II of the trial
Time frame: After 3 months and 30 days
Serum zinc concentration in stage III of the trial
Time frame: At baseline
Body mass in stage I
Time frame: After 3 months
Body mass in stage II
Time frame: After 3 months and 30 days
Body mass in stage III
Time frame: At baseline
Body height in stage I
Time frame: After 3 months
Body height in stage II
Time frame: After 3 months and 30 days
Body height in stage III
Time frame: At baseline
Blood pressure in stage I
Time frame: After 3 months
Blood pressure in stage II
Time frame: After 3 months and 30 days
Blood pressure in stage III
Time frame: At baseline
Zinc concentration in erythrocytes in stage I
Time frame: After 3 months
Zinc concentration in erythrocytes in stage II
Time frame: After 3 months and 30 days
Zinc concentration in erythrocytes in stage III
Time frame: At baseline
Zinc concentration in urine in stage I
Time frame: After 3 months
Zinc concentration in urine in stage II
Time frame: After 3 months and 30 days
Zinc concentration in urine in stage III
Time frame: At baseline
Zinc content in hair in stage I
Time frame: After 3 months
Zinc content in hair in stage II
Time frame: After 3 months and 30 days
Zinc content in hair in stage III
Time frame: At baseline
Iron concentration in serum in stage I
Time frame: After 3 months
Iron concentration in serum in stage II
Time frame: After 3 months and 30 days
Iron concentration in serum in stage III
Time frame: At baseline
Iron concentration in erythrocytes in stage I
Time frame: After 3 months
Iron concentration in erythrocytes in stage II
Time frame: After 3 months and 30 days
Iron concentration in erythrocytes in stage III
Time frame: At baseline
Iron concentration in urine in stage I
Time frame: After 3 months
Iron concentration in urine in stage II
Time frame: After 3 months and 30 days
Iron concentration in urine in stage III
Time frame: At baseline
Iron content in hair in stage I
Time frame: After 3 months
Iron content in hair in stage II
Time frame: After 3 months and 30 days
Iron content in hair in stage III
Time frame: At baseline
Serum copper concentration in stage I
Time frame: After 3 months
Serum copper concentration in stage II
Time frame: After 3 months and 30 days
Serum copper concentration in stage III
Time frame: At baseline
Erythrocytes copper concentration in stage I
Time frame: After 3 months
Erythrocytes copper concentration in stage II
Time frame: After 3 months and 30 days
Erythrocytes copper concentration in stage III
Time frame: At baseline
Urine copper concentration in stage I
Time frame: After 3 months
Urine copper concentration in stage II
Time frame: After 3 months and 30 days
Urine copper concentration in stage III
Time frame: At baseline
Hair copper content in stage I
Time frame: After 3 months
Hair copper content in stage II
Time frame: After 3 months and 30 days
Hair copper content in stage III
Time frame: At baseline
Glucose serum concentration in stage I
Time frame: After 3 months
Glucose serum concentration in stage II
Time frame: After 3 months and 30 days
Glucose serum concentration in stage III
Time frame: At baseline
C-reactive protein serum concentration in stage I
Time frame: After 3 months
C-reactive protein serum concentration in stage II
Time frame: After 3 months and 30 days
C-reactive protein serum concentration in stage III
Poznan University of Life Sciences
Other
The Influence of Hypotensive Drugs on Zinc, Copper and Iron Status in Experimental and Clinical Studies.
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