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| Name | Class |
|---|---|
| Poznan University of Medical Sciences | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group/arm C (control group) | Active Comparator | Group C in the third stage (30 days) continued drug use with no change in diet and no mineral supplementation. |
|
| group/arm D (diet group) | Active Comparator | Group D in the third stage (30 days) received an optimal-mineral-content properly balanced diet enriched in food with high zinc content. |
|
| group/arm S (supplementation group) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| group/arm C (control group) | Dietary Supplement | Group C in the third stage (30 days) continued drug use with no change in diet and no mineral supplementation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum zinc- stage I | Serum zinc concentration in stage I of the trial | At baseline |
| Serum zinc- stage II | Serum zinc concentration in stage II of the trial | After 3 months |
| Serum zinc- stage III | Serum zinc concentration in stage III of the trial | After 3 months and 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass- stage I | Body mass in stage I | At baseline |
| Body mass- stage II | Body mass in stage II | After 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanna Suliburska, Assoc. Prof. | Poznan University of Life Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan University of Life Sciences | Poznan | 60-624 | Poland |
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| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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Three stages of the study:
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| group/arm D (diet group) | Dietary Supplement | Group D in the third stage (30 days) received an optimal-mineral-content properly balanced diet enriched in food with high zinc content. |
|
| group/arm S (supplementation group) | Dietary Supplement | 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. |
|
| Body mass- stage III | Body mass in stage III | After 3 months and 30 days |
| Body height- stage I | Body height in stage I | At baseline |
| Body height- stage II | Body height in stage II | After 3 months |
| Body height- stage III | Body height in stage III | After 3 months and 30 days |
| Blood pressure- stage I | Blood pressure in stage I | At baseline |
| Blood pressure- stage II | Blood pressure in stage II | After 3 months |
| Blood pressure- stage III | Blood pressure in stage III | After 3 months and 30 days |
| Erythrocytes zinc- stage I | Zinc concentration in erythrocytes in stage I | At baseline |
| Erythrocytes zinc- stage II | Zinc concentration in erythrocytes in stage II | After 3 months |
| Erythrocytes zinc- stage III | Zinc concentration in erythrocytes in stage III | After 3 months and 30 days |
| Urine zinc- stage I | Zinc concentration in urine in stage I | At baseline |
| Urine zinc- stage II | Zinc concentration in urine in stage II | After 3 months |
| Urine zinc- stage III | Zinc concentration in urine in stage III | After 3 months and 30 days |
| Hair zinc- stage I | Zinc content in hair in stage I | At baseline |
| Hair zinc- stage II | Zinc content in hair in stage II | After 3 months |
| Hair zinc- stage III | Zinc content in hair in stage III | After 3 months and 30 days |
| Serum iron- stage I | Iron concentration in serum in stage I | At baseline |
| Serum iron- stage II | Iron concentration in serum in stage II | After 3 months |
| Serum iron- stage III | Iron concentration in serum in stage III | After 3 months and 30 days |
| Erythrocytes iron- stage I | Iron concentration in erythrocytes in stage I | At baseline |
| Erythrocytes iron- stage II | Iron concentration in erythrocytes in stage II | After 3 months |
| Erythrocytes iron- stage III | Iron concentration in erythrocytes in stage III | After 3 months and 30 days |
| Urine iron- stage I | Iron concentration in urine in stage I | At baseline |
| Urine iron- stage II | Iron concentration in urine in stage II | After 3 months |
| Urine iron- stage III | Iron concentration in urine in stage III | After 3 months and 30 days |
| Hair iron- stage I | Iron content in hair in stage I | At baseline |
| Hair iron- stage II | Iron content in hair in stage II | After 3 months |
| Hair iron- stage III | Iron content in hair in stage III | After 3 months and 30 days |
| Serum copper- stage I | Serum copper concentration in stage I | At baseline |
| Serum copper- stage II | Serum copper concentration in stage II | After 3 months |
| Serum copper- stage III | Serum copper concentration in stage III | After 3 months and 30 days |
| Erythrocytes copper- stage I | Erythrocytes copper concentration in stage I | At baseline |
| Erythrocytes copper- stage II | Erythrocytes copper concentration in stage II | After 3 months |
| Erythrocytes copper- stage III | Erythrocytes copper concentration in stage III | After 3 months and 30 days |
| Urine copper- stage I | Urine copper concentration in stage I | At baseline |
| Urine copper- stage II | Urine copper concentration in stage II | After 3 months |
| Urine copper- stage III | Urine copper concentration in stage III | After 3 months and 30 days |
| Hair copper- stage I | Hair copper content in stage I | At baseline |
| Hair copper- stage II | Hair copper content in stage II | After 3 months |
| Hair copper- stage III | Hair copper content in stage III | After 3 months and 30 days |
| Glucose- stage I | Glucose serum concentration in stage I | At baseline |
| Glucose- stage II | Glucose serum concentration in stage II | After 3 months |
| Glucose- stage III | Glucose serum concentration in stage III | After 3 months and 30 days |
| C-reactive protein- stage I | C-reactive protein serum concentration in stage I | At baseline |
| C-reactive protein- stage II | C-reactive protein serum concentration in stage II | After 3 months |
| C-reactive protein- stage III | C-reactive protein serum concentration in stage III | After 3 months and 30 days |
| D008722 | Methods |