Hypertension, Mineral Deficiency, Nutritional Disorder
Conditions
Keywords
hypertension,, zinc, zinc supplementation, antihypertensive monotherapy, mineral status
Brief 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.
Interventions
DIETARY_SUPPLEMENTgroup/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_SUPPLEMENTgroup/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_SUPPLEMENTgroup/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.
Sponsors
Poznan University of Medical Sciences
Poznan University of Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Three stages of the study: * stage 1- diagnosis of primary hypertension * stage 2 (lasting 3 months) - antihypertensive monotherapy in all subjects * stage 3 (lasting 30 days) - 3 groups (3 arms): group/arm C (control group), group/arm D (diet group) and group/arm S (supplementation group).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* informed written consent; * age 18-65 years; * primary hypertension; * beginning monotherapy with an antihypertensive drug; * stable body weight (less than 3 kg self-reported change during the three months prior to enrollment).
Exclusion criteria
* any secondary form of hypertension; * the use of mineral supplements within the three months prior to enrollment; * lipid disorders requiring treatment in the three months prior to the trial; * a history of ischemic heart disease, stroke, congestive heart failure, * clinically significant arrhythmia or conduction disorders, peripheral artery or vein disease, diabetes mellitus, abnormal renal, liver or thyroid gland function, * clinically significant chronic or acute inflammatory process within the respiratory, genitourinary, or digestive tract, or in the oral cavity, larynx, pharynx, or in the paranasal sinuses, or connective tissue diseases, arthritis, or malignancy; * infection in the month prior to enrollment, * having an pacemaker implanted; * alcohol, nicotine or drug abuse; * mental disorders; * pregnancy, childbirth or lactation at enrollment or in the three months prior to enrollment; * or any other condition that, in the opinion of investigators, would make participation in the study not in the best interest of the subject, or could prevent, limit, or confound the efficacy of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum zinc- stage I | At baseline | Serum zinc concentration in stage I of the trial |
| Serum zinc- stage II | After 3 months | Serum zinc concentration in stage II of the trial |
| Serum zinc- stage III | After 3 months and 30 days | Serum zinc concentration in stage III of the trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body mass- stage III | After 3 months and 30 days | Body mass in stage III |
| Body height- stage I | At baseline | Body height in stage I |
| Body height- stage II | After 3 months | Body height in stage II |
| Blood pressure- stage I | At baseline | Blood pressure in stage I |
| Blood pressure- stage II | After 3 months | Blood pressure in stage II |
| Blood pressure- stage III | After 3 months and 30 days | Blood pressure in stage III |
| Erythrocytes zinc- stage I | At baseline | Zinc concentration in erythrocytes in stage I |
| Erythrocytes zinc- stage II | After 3 months | Zinc concentration in erythrocytes in stage II |
| Erythrocytes zinc- stage III | After 3 months and 30 days | Zinc concentration in erythrocytes in stage III |
| Urine zinc- stage I | At baseline | Zinc concentration in urine in stage I |
| Urine zinc- stage II | After 3 months | Zinc concentration in urine in stage II |
| Urine zinc- stage III | After 3 months and 30 days | Zinc concentration in urine in stage III |
| Hair zinc- stage I | At baseline | Zinc content in hair in stage I |
| Hair zinc- stage II | After 3 months | Zinc content in hair in stage II |
| Hair zinc- stage III | After 3 months and 30 days | Zinc content in hair in stage III |
| Serum iron- stage I | At baseline | Iron concentration in serum in stage I |
| Serum iron- stage II | After 3 months | Iron concentration in serum in stage II |
| Serum iron- stage III | After 3 months and 30 days | Iron concentration in serum in stage III |
| Erythrocytes iron- stage I | At baseline | Iron concentration in erythrocytes in stage I |
| Erythrocytes iron- stage II | After 3 months | Iron concentration in erythrocytes in stage II |
| Erythrocytes iron- stage III | After 3 months and 30 days | Iron concentration in erythrocytes in stage III |
| Urine iron- stage I | At baseline | Iron concentration in urine in stage I |
| Urine iron- stage II | After 3 months | Iron concentration in urine in stage II |
| Urine iron- stage III | After 3 months and 30 days | Iron concentration in urine in stage III |
| Hair iron- stage I | At baseline | Iron content in hair in stage I |
| Hair iron- stage II | After 3 months | Iron content in hair in stage II |
| Hair iron- stage III | After 3 months and 30 days | Iron content in hair in stage III |
| Serum copper- stage I | At baseline | Serum copper concentration in stage I |
| Serum copper- stage II | After 3 months | Serum copper concentration in stage II |
| Serum copper- stage III | After 3 months and 30 days | Serum copper concentration in stage III |
| Erythrocytes copper- stage I | At baseline | Erythrocytes copper concentration in stage I |
| Erythrocytes copper- stage II | After 3 months | Erythrocytes copper concentration in stage II |
| Erythrocytes copper- stage III | After 3 months and 30 days | Erythrocytes copper concentration in stage III |
| Urine copper- stage I | At baseline | Urine copper concentration in stage I |
| Urine copper- stage II | After 3 months | Urine copper concentration in stage II |
| Urine copper- stage III | After 3 months and 30 days | Urine copper concentration in stage III |
| Hair copper- stage I | At baseline | Hair copper content in stage I |
| Hair copper- stage II | After 3 months | Hair copper content in stage II |
| Hair copper- stage III | After 3 months and 30 days | Hair copper content in stage III |
| Glucose- stage I | At baseline | Glucose serum concentration in stage I |
| Glucose- stage II | After 3 months | Glucose serum concentration in stage II |
| Body height- stage III | After 3 months and 30 days | Body height in stage III |
| C-reactive protein- stage I | At baseline | C-reactive protein serum concentration in stage I |
| C-reactive protein- stage II | After 3 months | C-reactive protein serum concentration in stage II |
| C-reactive protein- stage III | After 3 months and 30 days | C-reactive protein serum concentration in stage III |
| Glucose- stage III | After 3 months and 30 days | Glucose serum concentration in stage III |
| Body mass- stage I | At baseline | Body mass in stage I |
| Body mass- stage II | After 3 months | Body mass in stage II |
Countries
Poland
Outcome results
None listed