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.

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Nutritional Disorder; Mineral Deficiency
• Intervention / Treatment: Dietary supplement: group/arm C (control group); Dietary supplement: group/arm D (diet group); Dietary supplement: group/arm S (supplementation group)

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Poznań, Poland, 60-624
    • Poznan University of Life Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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 C (control group); Group C in the third stage (30 days) continued drug use with no change in diet and no mineral supplementation.
Active Comparator: 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 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Poznan University of Life Sciences
• Collaborators: Poznan University of Medical Sciences
• Investigators: Study Chair: Joanna Suliburska, Assoc. Prof., Poznan University of Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2016
• Primary Completion (Actual): December 29, 2016
• Study Completion (Actual): December 30, 2016

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 14, 2018
• Last Update Submitted That Met QC Criteria: March 7, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: zinc; hypertension,; zinc supplementation; antihypertensive monotherapy; mineral status
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Nutrition Disorders
• Other Study ID Numbers: 86/09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No