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

Hypertension Clinical Trial

Official title:

The Influence of Hypotensive Drugs on Zinc, Copper and Iron Status in Experimental and Clinical Studies.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03465462
• Other study ID #: 86/09
• Status: Completed
• Phase: N/A
• First received: March 1, 2018
• Last updated: March 7, 2018
• Start date: January 2, 2016
• Est. completion date: December 30, 2016

Study information

• Verified date: March 2018
• Source: Poznan University of Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 30, 2016
• Est. primary completion date: December 29, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Mineral Deficiency
• Nutrition Disorders
• Nutritional Disorder

Intervention

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.
• 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 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.

Locations

Country	Name	City	State
Poland	Poznan University of Life Sciences	Poznan

Sponsors (2)

Lead Sponsor	Collaborator
Poznan University of Life Sciences	Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum zinc- stage I	Serum zinc concentration in stage I of the trial	At baseline
Primary	Serum zinc- stage II	Serum zinc concentration in stage II of the trial	After 3 months
Primary	Serum zinc- stage III	Serum zinc concentration in stage III of the trial	After 3 months and 30 days
Secondary	Body mass- stage I	Body mass in stage I	At baseline
Secondary	Body mass- stage II	Body mass in stage II	After 3 months
Secondary	Body mass- stage III	Body mass in stage III	After 3 months and 30 days
Secondary	Body height- stage I	Body height in stage I	At baseline
Secondary	Body height- stage II	Body height in stage II	After 3 months
Secondary	Body height- stage III	Body height in stage III	After 3 months and 30 days
Secondary	Blood pressure- stage I	Blood pressure in stage I	At baseline
Secondary	Blood pressure- stage II	Blood pressure in stage II	After 3 months
Secondary	Blood pressure- stage III	Blood pressure in stage III	After 3 months and 30 days
Secondary	Erythrocytes zinc- stage I	Zinc concentration in erythrocytes in stage I	At baseline
Secondary	Erythrocytes zinc- stage II	Zinc concentration in erythrocytes in stage II	After 3 months
Secondary	Erythrocytes zinc- stage III	Zinc concentration in erythrocytes in stage III	After 3 months and 30 days
Secondary	Urine zinc- stage I	Zinc concentration in urine in stage I	At baseline
Secondary	Urine zinc- stage II	Zinc concentration in urine in stage II	After 3 months
Secondary	Urine zinc- stage III	Zinc concentration in urine in stage III	After 3 months and 30 days
Secondary	Hair zinc- stage I	Zinc content in hair in stage I	At baseline
Secondary	Hair zinc- stage II	Zinc content in hair in stage II	After 3 months
Secondary	Hair zinc- stage III	Zinc content in hair in stage III	After 3 months and 30 days
Secondary	Serum iron- stage I	Iron concentration in serum in stage I	At baseline
Secondary	Serum iron- stage II	Iron concentration in serum in stage II	After 3 months
Secondary	Serum iron- stage III	Iron concentration in serum in stage III	After 3 months and 30 days
Secondary	Erythrocytes iron- stage I	Iron concentration in erythrocytes in stage I	At baseline
Secondary	Erythrocytes iron- stage II	Iron concentration in erythrocytes in stage II	After 3 months
Secondary	Erythrocytes iron- stage III	Iron concentration in erythrocytes in stage III	After 3 months and 30 days
Secondary	Urine iron- stage I	Iron concentration in urine in stage I	At baseline
Secondary	Urine iron- stage II	Iron concentration in urine in stage II	After 3 months
Secondary	Urine iron- stage III	Iron concentration in urine in stage III	After 3 months and 30 days
Secondary	Hair iron- stage I	Iron content in hair in stage I	At baseline
Secondary	Hair iron- stage II	Iron content in hair in stage II	After 3 months
Secondary	Hair iron- stage III	Iron content in hair in stage III	After 3 months and 30 days
Secondary	Serum copper- stage I	Serum copper concentration in stage I	At baseline
Secondary	Serum copper- stage II	Serum copper concentration in stage II	After 3 months
Secondary	Serum copper- stage III	Serum copper concentration in stage III	After 3 months and 30 days
Secondary	Erythrocytes copper- stage I	Erythrocytes copper concentration in stage I	At baseline
Secondary	Erythrocytes copper- stage II	Erythrocytes copper concentration in stage II	After 3 months
Secondary	Erythrocytes copper- stage III	Erythrocytes copper concentration in stage III	After 3 months and 30 days
Secondary	Urine copper- stage I	Urine copper concentration in stage I	At baseline
Secondary	Urine copper- stage II	Urine copper concentration in stage II	After 3 months
Secondary	Urine copper- stage III	Urine copper concentration in stage III	After 3 months and 30 days
Secondary	Hair copper- stage I	Hair copper content in stage I	At baseline
Secondary	Hair copper- stage II	Hair copper content in stage II	After 3 months
Secondary	Hair copper- stage III	Hair copper content in stage III	After 3 months and 30 days
Secondary	Glucose- stage I	Glucose serum concentration in stage I	At baseline
Secondary	Glucose- stage II	Glucose serum concentration in stage II	After 3 months
Secondary	Glucose- stage III	Glucose serum concentration in stage III	After 3 months and 30 days
Secondary	C-reactive protein- stage I	C-reactive protein serum concentration in stage I	At baseline
Secondary	C-reactive protein- stage II	C-reactive protein serum concentration in stage II	After 3 months
Secondary	C-reactive protein- stage III	C-reactive protein serum concentration in stage III	After 3 months and 30 days