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

Primary Purpose

Nutritional Disorder, Hypertension, Mineral Deficiency

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
group/arm C (control group)
group/arm D (diet group)
group/arm S (supplementation group)
Sponsored by
Poznan University of Life Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nutritional Disorder focused on measuring hypertension,, zinc, zinc supplementation, antihypertensive monotherapy, mineral status

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Poznan University of Life Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

group/arm C (control group)

group/arm D (diet group)

group/arm S (supplementation group)

Arm Description

Group C in the third stage (30 days) continued drug use with no change in diet and no mineral supplementation.

Group D in the third stage (30 days) received an optimal-mineral-content properly balanced diet enriched in food with high zinc content.

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.

Outcomes

Primary Outcome Measures

Serum zinc- stage I
Serum zinc concentration in stage I of the trial
Serum zinc- stage II
Serum zinc concentration in stage II of the trial
Serum zinc- stage III
Serum zinc concentration in stage III of the trial

Secondary Outcome Measures

Body mass- stage I
Body mass in stage I
Body mass- stage II
Body mass in stage II
Body mass- stage III
Body mass in stage III
Body height- stage I
Body height in stage I
Body height- stage II
Body height in stage II
Body height- stage III
Body height in stage III
Blood pressure- stage I
Blood pressure in stage I
Blood pressure- stage II
Blood pressure in stage II
Blood pressure- stage III
Blood pressure in stage III
Erythrocytes zinc- stage I
Zinc concentration in erythrocytes in stage I
Erythrocytes zinc- stage II
Zinc concentration in erythrocytes in stage II
Erythrocytes zinc- stage III
Zinc concentration in erythrocytes in stage III
Urine zinc- stage I
Zinc concentration in urine in stage I
Urine zinc- stage II
Zinc concentration in urine in stage II
Urine zinc- stage III
Zinc concentration in urine in stage III
Hair zinc- stage I
Zinc content in hair in stage I
Hair zinc- stage II
Zinc content in hair in stage II
Hair zinc- stage III
Zinc content in hair in stage III
Serum iron- stage I
Iron concentration in serum in stage I
Serum iron- stage II
Iron concentration in serum in stage II
Serum iron- stage III
Iron concentration in serum in stage III
Erythrocytes iron- stage I
Iron concentration in erythrocytes in stage I
Erythrocytes iron- stage II
Iron concentration in erythrocytes in stage II
Erythrocytes iron- stage III
Iron concentration in erythrocytes in stage III
Urine iron- stage I
Iron concentration in urine in stage I
Urine iron- stage II
Iron concentration in urine in stage II
Urine iron- stage III
Iron concentration in urine in stage III
Hair iron- stage I
Iron content in hair in stage I
Hair iron- stage II
Iron content in hair in stage II
Hair iron- stage III
Iron content in hair in stage III
Serum copper- stage I
Serum copper concentration in stage I
Serum copper- stage II
Serum copper concentration in stage II
Serum copper- stage III
Serum copper concentration in stage III
Erythrocytes copper- stage I
Erythrocytes copper concentration in stage I
Erythrocytes copper- stage II
Erythrocytes copper concentration in stage II
Erythrocytes copper- stage III
Erythrocytes copper concentration in stage III
Urine copper- stage I
Urine copper concentration in stage I
Urine copper- stage II
Urine copper concentration in stage II
Urine copper- stage III
Urine copper concentration in stage III
Hair copper- stage I
Hair copper content in stage I
Hair copper- stage II
Hair copper content in stage II
Hair copper- stage III
Hair copper content in stage III
Glucose- stage I
Glucose serum concentration in stage I
Glucose- stage II
Glucose serum concentration in stage II
Glucose- stage III
Glucose serum concentration in stage III
C-reactive protein- stage I
C-reactive protein serum concentration in stage I
C-reactive protein- stage II
C-reactive protein serum concentration in stage II
C-reactive protein- stage III
C-reactive protein serum concentration in stage III

Full Information

First Posted
March 1, 2018
Last Updated
March 7, 2018
Sponsor
Poznan University of Life Sciences
Collaborators
Poznan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03465462
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2, 2016 (Actual)
Primary Completion Date
December 29, 2016 (Actual)
Study Completion Date
December 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Life Sciences
Collaborators
Poznan University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional Disorder, Hypertension, Mineral Deficiency
Keywords
hypertension,, zinc, zinc supplementation, antihypertensive monotherapy, mineral status

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group/arm C (control group)
Arm Type
Active Comparator
Arm Description
Group C in the third stage (30 days) continued drug use with no change in diet and no mineral supplementation.
Arm Title
group/arm D (diet group)
Arm Type
Active Comparator
Arm Description
Group D in the third stage (30 days) received an optimal-mineral-content properly balanced diet enriched in food with high zinc content.
Arm Title
group/arm S (supplementation group)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
group/arm C (control group)
Intervention Description
Group C in the third stage (30 days) continued drug use with no change in diet and no mineral supplementation.
Intervention Type
Dietary Supplement
Intervention Name(s)
group/arm D (diet group)
Intervention Description
Group D in the third stage (30 days) received an optimal-mineral-content properly balanced diet enriched in food with high zinc content.
Intervention Type
Dietary Supplement
Intervention Name(s)
group/arm S (supplementation group)
Intervention Description
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 Measure Information:
Title
Serum zinc- stage I
Description
Serum zinc concentration in stage I of the trial
Time Frame
At baseline
Title
Serum zinc- stage II
Description
Serum zinc concentration in stage II of the trial
Time Frame
After 3 months
Title
Serum zinc- stage III
Description
Serum zinc concentration in stage III of the trial
Time Frame
After 3 months and 30 days
Secondary Outcome Measure Information:
Title
Body mass- stage I
Description
Body mass in stage I
Time Frame
At baseline
Title
Body mass- stage II
Description
Body mass in stage II
Time Frame
After 3 months
Title
Body mass- stage III
Description
Body mass in stage III
Time Frame
After 3 months and 30 days
Title
Body height- stage I
Description
Body height in stage I
Time Frame
At baseline
Title
Body height- stage II
Description
Body height in stage II
Time Frame
After 3 months
Title
Body height- stage III
Description
Body height in stage III
Time Frame
After 3 months and 30 days
Title
Blood pressure- stage I
Description
Blood pressure in stage I
Time Frame
At baseline
Title
Blood pressure- stage II
Description
Blood pressure in stage II
Time Frame
After 3 months
Title
Blood pressure- stage III
Description
Blood pressure in stage III
Time Frame
After 3 months and 30 days
Title
Erythrocytes zinc- stage I
Description
Zinc concentration in erythrocytes in stage I
Time Frame
At baseline
Title
Erythrocytes zinc- stage II
Description
Zinc concentration in erythrocytes in stage II
Time Frame
After 3 months
Title
Erythrocytes zinc- stage III
Description
Zinc concentration in erythrocytes in stage III
Time Frame
After 3 months and 30 days
Title
Urine zinc- stage I
Description
Zinc concentration in urine in stage I
Time Frame
At baseline
Title
Urine zinc- stage II
Description
Zinc concentration in urine in stage II
Time Frame
After 3 months
Title
Urine zinc- stage III
Description
Zinc concentration in urine in stage III
Time Frame
After 3 months and 30 days
Title
Hair zinc- stage I
Description
Zinc content in hair in stage I
Time Frame
At baseline
Title
Hair zinc- stage II
Description
Zinc content in hair in stage II
Time Frame
After 3 months
Title
Hair zinc- stage III
Description
Zinc content in hair in stage III
Time Frame
After 3 months and 30 days
Title
Serum iron- stage I
Description
Iron concentration in serum in stage I
Time Frame
At baseline
Title
Serum iron- stage II
Description
Iron concentration in serum in stage II
Time Frame
After 3 months
Title
Serum iron- stage III
Description
Iron concentration in serum in stage III
Time Frame
After 3 months and 30 days
Title
Erythrocytes iron- stage I
Description
Iron concentration in erythrocytes in stage I
Time Frame
At baseline
Title
Erythrocytes iron- stage II
Description
Iron concentration in erythrocytes in stage II
Time Frame
After 3 months
Title
Erythrocytes iron- stage III
Description
Iron concentration in erythrocytes in stage III
Time Frame
After 3 months and 30 days
Title
Urine iron- stage I
Description
Iron concentration in urine in stage I
Time Frame
At baseline
Title
Urine iron- stage II
Description
Iron concentration in urine in stage II
Time Frame
After 3 months
Title
Urine iron- stage III
Description
Iron concentration in urine in stage III
Time Frame
After 3 months and 30 days
Title
Hair iron- stage I
Description
Iron content in hair in stage I
Time Frame
At baseline
Title
Hair iron- stage II
Description
Iron content in hair in stage II
Time Frame
After 3 months
Title
Hair iron- stage III
Description
Iron content in hair in stage III
Time Frame
After 3 months and 30 days
Title
Serum copper- stage I
Description
Serum copper concentration in stage I
Time Frame
At baseline
Title
Serum copper- stage II
Description
Serum copper concentration in stage II
Time Frame
After 3 months
Title
Serum copper- stage III
Description
Serum copper concentration in stage III
Time Frame
After 3 months and 30 days
Title
Erythrocytes copper- stage I
Description
Erythrocytes copper concentration in stage I
Time Frame
At baseline
Title
Erythrocytes copper- stage II
Description
Erythrocytes copper concentration in stage II
Time Frame
After 3 months
Title
Erythrocytes copper- stage III
Description
Erythrocytes copper concentration in stage III
Time Frame
After 3 months and 30 days
Title
Urine copper- stage I
Description
Urine copper concentration in stage I
Time Frame
At baseline
Title
Urine copper- stage II
Description
Urine copper concentration in stage II
Time Frame
After 3 months
Title
Urine copper- stage III
Description
Urine copper concentration in stage III
Time Frame
After 3 months and 30 days
Title
Hair copper- stage I
Description
Hair copper content in stage I
Time Frame
At baseline
Title
Hair copper- stage II
Description
Hair copper content in stage II
Time Frame
After 3 months
Title
Hair copper- stage III
Description
Hair copper content in stage III
Time Frame
After 3 months and 30 days
Title
Glucose- stage I
Description
Glucose serum concentration in stage I
Time Frame
At baseline
Title
Glucose- stage II
Description
Glucose serum concentration in stage II
Time Frame
After 3 months
Title
Glucose- stage III
Description
Glucose serum concentration in stage III
Time Frame
After 3 months and 30 days
Title
C-reactive protein- stage I
Description
C-reactive protein serum concentration in stage I
Time Frame
At baseline
Title
C-reactive protein- stage II
Description
C-reactive protein serum concentration in stage II
Time Frame
After 3 months
Title
C-reactive protein- stage III
Description
C-reactive protein serum concentration in stage III
Time Frame
After 3 months and 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Suliburska, Assoc. Prof.
Organizational Affiliation
Poznan University of Life Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Poznan University of Life Sciences
City
Poznań
ZIP/Postal Code
60-624
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

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

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