Nutritional DisorderNCT03465462
The Influence of Hypotensive Drugs on Mineral Status in Experimental and Clinical Studies
A study testing group/arm D (diet group) and group/arm S (supplementation group) in people with Nutritional Disorder and Hypertension, run by Poznan University of Life Sciences at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Disorder, Hypertension, Mineral Deficiency
- What is being tested?
- group/arm D (diet group) and group/arm S (supplementation group)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 sitePoland
- Study dates
- 2 Jan 2016to 30 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nutritional Disorder, Hypertension, Mineral Deficiency
- Being tested
- group/arm C (control group), group/arm D (diet group), group/arm S (supplementation group)
- Keywords
- hypertension,, zinc, zinc supplementation, antihypertensive monotherapy, mineral status
- Medical subject headings
- Nutrition Disorders, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group/arm C (control group)Dietary supplement
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)Dietary supplement
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)Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| group/arm C (control group) | Active comparator | Group C in the third stage (30 days) continued drug use with no change in diet and no mineral supplementation. Receives: Dietary Supplement: group/arm C (control group) |
| group/arm D (diet group) | Active comparator | Group D in the third stage (30 days) received an optimal-mineral-content properly balanced diet enriched in food with high zinc content. Receives: Dietary Supplement: group/arm D (diet group) |
| group/arm S (supplementation group) | Active comparator | 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. Receives: Dietary Supplement: group/arm S (supplementation group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum zinc- stage I
Serum zinc concentration in stage I of the trial
Measured: At baseline
Serum zinc- stage II
Serum zinc concentration in stage II of the trial
Measured: After 3 months
Serum zinc- stage III
Serum zinc concentration in stage III of the trial
Measured: After 3 months and 30 days
Secondary outcomes (48)
Body mass- stage I
Body mass in stage I
Measured: At baseline
Body mass- stage II
Body mass in stage II
Measured: After 3 months
Body mass- stage III
Body mass in stage III
Measured: After 3 months and 30 days
Body height- stage I
Body height in stage I
Measured: At baseline
Body height- stage II
Body height in stage II
Measured: After 3 months
Body height- stage III
Body height in stage III
Measured: After 3 months and 30 days
Blood pressure- stage I
Blood pressure in stage I
Measured: At baseline
Blood pressure- stage II
Blood pressure in stage II
Measured: After 3 months
Blood pressure- stage III
Blood pressure in stage III
Measured: After 3 months and 30 days
Erythrocytes zinc- stage I
Zinc concentration in erythrocytes in stage I
Measured: At baseline
Erythrocytes zinc- stage II
Zinc concentration in erythrocytes in stage II
Measured: After 3 months
Erythrocytes zinc- stage III
Zinc concentration in erythrocytes in stage III
Measured: After 3 months and 30 days
Urine zinc- stage I
Zinc concentration in urine in stage I
Measured: At baseline
Urine zinc- stage II
Zinc concentration in urine in stage II
Measured: After 3 months
Urine zinc- stage III
Zinc concentration in urine in stage III
Measured: After 3 months and 30 days
Hair zinc- stage I
Zinc content in hair in stage I
Measured: At baseline
Hair zinc- stage II
Zinc content in hair in stage II
Measured: After 3 months
Hair zinc- stage III
Zinc content in hair in stage III
Measured: After 3 months and 30 days
Serum iron- stage I
Iron concentration in serum in stage I
Measured: At baseline
Serum iron- stage II
Iron concentration in serum in stage II
Measured: After 3 months
Serum iron- stage III
Iron concentration in serum in stage III
Measured: After 3 months and 30 days
Erythrocytes iron- stage I
Iron concentration in erythrocytes in stage I
Measured: At baseline
Erythrocytes iron- stage II
Iron concentration in erythrocytes in stage II
Measured: After 3 months
Erythrocytes iron- stage III
Iron concentration in erythrocytes in stage III
Measured: After 3 months and 30 days
Urine iron- stage I
Iron concentration in urine in stage I
Measured: At baseline
Urine iron- stage II
Iron concentration in urine in stage II
Measured: After 3 months
Urine iron- stage III
Iron concentration in urine in stage III
Measured: After 3 months and 30 days
Hair iron- stage I
Iron content in hair in stage I
Measured: At baseline
Hair iron- stage II
Iron content in hair in stage II
Measured: After 3 months
Hair iron- stage III
Iron content in hair in stage III
Measured: After 3 months and 30 days
Serum copper- stage I
Serum copper concentration in stage I
Measured: At baseline
Serum copper- stage II
Serum copper concentration in stage II
Measured: After 3 months
Serum copper- stage III
Serum copper concentration in stage III
Measured: After 3 months and 30 days
Erythrocytes copper- stage I
Erythrocytes copper concentration in stage I
Measured: At baseline
Erythrocytes copper- stage II
Erythrocytes copper concentration in stage II
Measured: After 3 months
Erythrocytes copper- stage III
Erythrocytes copper concentration in stage III
Measured: After 3 months and 30 days
Urine copper- stage I
Urine copper concentration in stage I
Measured: At baseline
Urine copper- stage II
Urine copper concentration in stage II
Measured: After 3 months
Urine copper- stage III
Urine copper concentration in stage III
Measured: After 3 months and 30 days
Hair copper- stage I
Hair copper content in stage I
Measured: At baseline
Hair copper- stage II
Hair copper content in stage II
Measured: After 3 months
Hair copper- stage III
Hair copper content in stage III
Measured: After 3 months and 30 days
Glucose- stage I
Glucose serum concentration in stage I
Measured: At baseline
Glucose- stage II
Glucose serum concentration in stage II
Measured: After 3 months
Glucose- stage III
Glucose serum concentration in stage III
Measured: After 3 months and 30 days
C-reactive protein- stage I
C-reactive protein serum concentration in stage I
Measured: At baseline
C-reactive protein- stage II
C-reactive protein serum concentration in stage II
Measured: After 3 months
C-reactive protein- stage III
C-reactive protein serum concentration in stage III
Measured: After 3 months and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start2 Jan 2016
- Primary completion29 Dec 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Life Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Poznan University of Medical Sciences
- Responsible party
- Principal investigator, Joanna Suliburska, Poznan University of Life Sciences
- Investigators
- Joanna Suliburska, Assoc. Prof., Study chair, Poznan University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465462
- Sponsor's protocol ID
- 86/09
- Status last verified
- Mar 2018
- First submitted
- 1 Mar 2018
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Hypotensive Drugs on Zinc, Copper and Iron Status in Experimental and Clinical Studies.
- ClinicalTrials.gov ID
- NCT03465462
- Acronym / sponsor ID
- 86/09
- Conditions
- Nutritional Disorder, Hypertension, Mineral Deficiency
- Keywords
- hypertension,, zinc, zinc supplementation, antihypertensive monotherapy, mineral status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Poznan University of Life SciencesUniversity, hospital or other
- Collaborators
- Poznan University of Medical Sciences
- Study start
- 2 Jan 2016 (actual)
- Primary completion
- 29 Dec 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| group/arm C (control group) | Active comparator | 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) | Active comparator | 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. |
| group/arm S (supplementation group) | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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/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/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) |
Primary outcome
Serum zinc- stage I
Time frame: At baseline
Serum zinc concentration in stage I of the trial
Serum zinc- stage II
Time frame: After 3 months
Serum zinc concentration in stage II of the trial
Serum zinc- stage III
Time frame: After 3 months and 30 days
Serum zinc concentration in stage III of the trial
48 secondary outcomes
Body mass- stage I
Time frame: At baseline
Body mass- stage II
Time frame: After 3 months
Body mass- stage III
Time frame: After 3 months and 30 days
Body height- stage I
Time frame: At baseline
Body height- stage II
Time frame: After 3 months
Body height- stage III
Time frame: After 3 months and 30 days
Blood pressure- stage I
Time frame: At baseline
Blood pressure- stage II
Time frame: After 3 months
Blood pressure- stage III
Time frame: After 3 months and 30 days
Erythrocytes zinc- stage I
Time frame: At baseline
Erythrocytes zinc- stage II
Time frame: After 3 months
Erythrocytes zinc- stage III
Time frame: After 3 months and 30 days
Urine zinc- stage I
Time frame: At baseline
Urine zinc- stage II
Time frame: After 3 months
Urine zinc- stage III
Time frame: After 3 months and 30 days
Hair zinc- stage I
Time frame: At baseline
Hair zinc- stage II
Time frame: After 3 months
Hair zinc- stage III
Time frame: After 3 months and 30 days
Serum iron- stage I
Time frame: At baseline
Serum iron- stage II
Time frame: After 3 months
Serum iron- stage III
Time frame: After 3 months and 30 days
Erythrocytes iron- stage I
Time frame: At baseline
Erythrocytes iron- stage II
Time frame: After 3 months
Erythrocytes iron- stage III
Time frame: After 3 months and 30 days
Urine iron- stage I
Time frame: At baseline
Urine iron- stage II
Time frame: After 3 months
Urine iron- stage III
Time frame: After 3 months and 30 days
Hair iron- stage I
Time frame: At baseline
Hair iron- stage II
Time frame: After 3 months
Hair iron- stage III
Time frame: After 3 months and 30 days
Serum copper- stage I
Time frame: At baseline
Serum copper- stage II
Time frame: After 3 months
Serum copper- stage III
Time frame: After 3 months and 30 days
Erythrocytes copper- stage I
Time frame: At baseline
Erythrocytes copper- stage II
Time frame: After 3 months
Erythrocytes copper- stage III
Time frame: After 3 months and 30 days
Urine copper- stage I
Time frame: At baseline
Urine copper- stage II
Time frame: After 3 months
Urine copper- stage III
Time frame: After 3 months and 30 days
Hair copper- stage I
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Suliburska, Assoc. Prof. study chair
Poznan University of Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group/arm D (diet group) and group/arm S (supplementation group) in people with Nutritional Disorder and Hypertension, run by Poznan University of Life Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum zinc- stage I (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.