The Influence of Hypotensive Drugs on Mineral Status in Experimental and Clinical Studies

Not Applicable

Completed

• Conditions: Nutritional Disorder; Mineral Deficiency; Hypertension
• Interventions: Dietary Supplement: group/arm C (control group); Dietary Supplement: group/arm D (diet group); Dietary Supplement: group/arm S (supplementation group)

• Registration Number: NCT03465462
• Lead Sponsor: Poznan University of Life Sciences

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.

Study Timeline

• Study Start: 2016-01-02
• Primary Completion: 2016-12-29
• Study Completion: 2016-12-30
• Status Verified: 2018-03
• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-07
• Last Update Submitted: 2018-03-07
• Study First Posted: 2018-03-14
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group/arm C (control group)	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.
group/arm D (diet group)	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.
group/arm S (supplementation group)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Serum copper- stage III	After 3 months and 30 days	Serum copper 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
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
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
Body height- stage III	After 3 months and 30 days	Body height in stage III
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
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
Glucose- stage III	After 3 months and 30 days	Glucose serum concentration 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

Trial Locations

Locations (1)

Poznan University of Life Sciences; 🇵🇱 Poznań, Poland