Clinical trial NCT03465462: The Influence of Hypotensive Drugs on Mineral Status in Experimental and Clinical Studies
Official title: The Influence of Hypotensive Drugs on Zinc, Copper and Iron Status in Experimental and Clinical Studies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Disorder
Hypertension
Mineral Deficiency
Keywords: hypertension,
zinc
zinc supplementation
antihypertensive monotherapy
mineral status
Lead sponsor: Poznan University of Life Sciences
Sponsor class: OTHER
Collaborators: name: Poznan University of Medical Sciences
First posted: 2018-03-14
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum zinc- stage I
timeFrame: At baseline
measure: Serum zinc- stage II
timeFrame: After 3 months
measure: Serum zinc- stage III
timeFrame: After 3 months and 30 days
Secondary outcomes:
measure: Body mass- stage I
timeFrame: At baseline
measure: Body mass- stage II
timeFrame: After 3 months
measure: Body mass- stage III
timeFrame: After 3 months and 30 days
measure: Body height- stage I
timeFrame: At baseline
measure: Body height- stage II
timeFrame: After 3 months
measure: Body height- stage III
timeFrame: After 3 months and 30 days
measure: Blood pressure- stage I
timeFrame: At baseline
measure: Blood pressure- stage II
timeFrame: After 3 months
measure: Blood pressure- stage III
timeFrame: After 3 months and 30 days
measure: Erythrocytes zinc- stage I
timeFrame: At baseline
measure: Erythrocytes zinc- stage II
timeFrame: After 3 months
measure: Erythrocytes zinc- stage III
timeFrame: After 3 months and 30 days
measure: Urine zinc- stage I
timeFrame: At baseline
measure: Urine zinc- stage II
timeFrame: After 3 months
measure: Urine zinc- stage III
timeFrame: After 3 months and 30 days
measure: Hair zinc- stage I
timeFrame: At baseline
measure: Hair zinc- stage II
timeFrame: After 3 months
measure: Hair zinc- stage III
timeFrame: After 3 months and 30 days
measure: Serum iron- stage I
timeFrame: At baseline
measure: Serum iron- stage II
timeFrame: After 3 months
measure: Serum iron- stage III
timeFrame: After 3 months and 30 days
measure: Erythrocytes iron- stage I
timeFrame: At baseline
measure: Erythrocytes iron- stage II
timeFrame: After 3 months
measure: Erythrocytes iron- stage III
timeFrame: After 3 months and 30 days
measure: Urine iron- stage I
timeFrame: At baseline
measure: Urine iron- stage II
timeFrame: After 3 months
measure: Urine iron- stage III
timeFrame: After 3 months and 30 days
measure: Hair iron- stage I
timeFrame: At baseline
measure: Hair iron- stage II
timeFrame: After 3 months
measure: Hair iron- stage III
timeFrame: After 3 months and 30 days
measure: Serum copper- stage I
timeFrame: At baseline
measure: Serum copper- stage II
timeFrame: After 3 months
measure: Serum copper- stage III
timeFrame: After 3 months and 30 days
measure: Erythrocytes copper- stage I
timeFrame: At baseline
measure: Erythrocytes copper- stage II
timeFrame: After 3 months
measure: Erythrocytes copper- stage III
timeFrame: After 3 months and 30 days
measure: Urine copper- stage I
timeFrame: At baseline
measure: Urine copper- stage II
timeFrame: After 3 months
measure: Urine copper- stage III
timeFrame: After 3 months and 30 days
measure: Hair copper- stage I
timeFrame: At baseline
measure: Hair copper- stage II
timeFrame: After 3 months
measure: Hair copper- stage III
timeFrame: After 3 months and 30 days
measure: Glucose- stage I
timeFrame: At baseline
measure: Glucose- stage II
timeFrame: After 3 months
measure: Glucose- stage III
timeFrame: After 3 months and 30 days
measure: C-reactive protein- stage I
timeFrame: At baseline
measure: C-reactive protein- stage II
timeFrame: After 3 months
measure: C-reactive protein- stage III
timeFrame: After 3 months and 30 days
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan University of Life Sciences
Study officials:
affiliation: Poznan University of Life Sciences
name: Joanna Suliburska, Assoc. Prof.
role: STUDY_CHAIR
References: