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Completed

NCT Number: NCT03465462

The Influence of Hypotensive Drugs on Mineral 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Poznan University of Life Sciences

Poznan, 60-624, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Serum zinc- stage I

    Time frame: At baseline

    Serum zinc concentration in stage I of the trial

  2. Serum zinc- stage II

    Time frame: After 3 months

    Serum zinc concentration in stage II of the trial

  3. Serum zinc- stage III

    Time frame: After 3 months and 30 days

    Serum zinc concentration in stage III of the trial

Secondary outcomes

  1. Body mass- stage I

    Time frame: At baseline

    Body mass in stage I

  2. Body mass- stage II

    Time frame: After 3 months

    Body mass in stage II

  3. Body mass- stage III

    Time frame: After 3 months and 30 days

    Body mass in stage III

  4. Body height- stage I

    Time frame: At baseline

    Body height in stage I

  5. Body height- stage II

    Time frame: After 3 months

    Body height in stage II

  6. Body height- stage III

    Time frame: After 3 months and 30 days

    Body height in stage III

  7. Blood pressure- stage I

    Time frame: At baseline

    Blood pressure in stage I

  8. Blood pressure- stage II

    Time frame: After 3 months

    Blood pressure in stage II

  9. Blood pressure- stage III

    Time frame: After 3 months and 30 days

    Blood pressure in stage III

  10. Erythrocytes zinc- stage I

    Time frame: At baseline

    Zinc concentration in erythrocytes in stage I

  11. Erythrocytes zinc- stage II

    Time frame: After 3 months

    Zinc concentration in erythrocytes in stage II

  12. Erythrocytes zinc- stage III

    Time frame: After 3 months and 30 days

    Zinc concentration in erythrocytes in stage III

  13. Urine zinc- stage I

    Time frame: At baseline

    Zinc concentration in urine in stage I

  14. Urine zinc- stage II

    Time frame: After 3 months

    Zinc concentration in urine in stage II

  15. Urine zinc- stage III

    Time frame: After 3 months and 30 days

    Zinc concentration in urine in stage III

  16. Hair zinc- stage I

    Time frame: At baseline

    Zinc content in hair in stage I

  17. Hair zinc- stage II

    Time frame: After 3 months

    Zinc content in hair in stage II

  18. Hair zinc- stage III

    Time frame: After 3 months and 30 days

    Zinc content in hair in stage III

  19. Serum iron- stage I

    Time frame: At baseline

    Iron concentration in serum in stage I

  20. Serum iron- stage II

    Time frame: After 3 months

    Iron concentration in serum in stage II

  21. Serum iron- stage III

    Time frame: After 3 months and 30 days

    Iron concentration in serum in stage III

  22. Erythrocytes iron- stage I

    Time frame: At baseline

    Iron concentration in erythrocytes in stage I

  23. Erythrocytes iron- stage II

    Time frame: After 3 months

    Iron concentration in erythrocytes in stage II

  24. Erythrocytes iron- stage III

    Time frame: After 3 months and 30 days

    Iron concentration in erythrocytes in stage III

  25. Urine iron- stage I

    Time frame: At baseline

    Iron concentration in urine in stage I

  26. Urine iron- stage II

    Time frame: After 3 months

    Iron concentration in urine in stage II

  27. Urine iron- stage III

    Time frame: After 3 months and 30 days

    Iron concentration in urine in stage III

  28. Hair iron- stage I

    Time frame: At baseline

    Iron content in hair in stage I

  29. Hair iron- stage II

    Time frame: After 3 months

    Iron content in hair in stage II

  30. Hair iron- stage III

    Time frame: After 3 months and 30 days

    Iron content in hair in stage III

  31. Serum copper- stage I

    Time frame: At baseline

    Serum copper concentration in stage I

  32. Serum copper- stage II

    Time frame: After 3 months

    Serum copper concentration in stage II

  33. Serum copper- stage III

    Time frame: After 3 months and 30 days

    Serum copper concentration in stage III

  34. Erythrocytes copper- stage I

    Time frame: At baseline

    Erythrocytes copper concentration in stage I

  35. Erythrocytes copper- stage II

    Time frame: After 3 months

    Erythrocytes copper concentration in stage II

  36. Erythrocytes copper- stage III

    Time frame: After 3 months and 30 days

    Erythrocytes copper concentration in stage III

  37. Urine copper- stage I

    Time frame: At baseline

    Urine copper concentration in stage I

  38. Urine copper- stage II

    Time frame: After 3 months

    Urine copper concentration in stage II

  39. Urine copper- stage III

    Time frame: After 3 months and 30 days

    Urine copper concentration in stage III

  40. Hair copper- stage I

    Time frame: At baseline

    Hair copper content in stage I

  41. Hair copper- stage II

    Time frame: After 3 months

    Hair copper content in stage II

  42. Hair copper- stage III

    Time frame: After 3 months and 30 days

    Hair copper content in stage III

  43. Glucose- stage I

    Time frame: At baseline

    Glucose serum concentration in stage I

  44. Glucose- stage II

    Time frame: After 3 months

    Glucose serum concentration in stage II

  45. Glucose- stage III

    Time frame: After 3 months and 30 days

    Glucose serum concentration in stage III

  46. C-reactive protein- stage I

    Time frame: At baseline

    C-reactive protein serum concentration in stage I

  47. C-reactive protein- stage II

    Time frame: After 3 months

    C-reactive protein serum concentration in stage II

  48. C-reactive protein- stage III

    Time frame: After 3 months and 30 days

    C-reactive protein serum concentration in stage III

Sponsors and collaborators

Lead sponsor

Poznan University of Life Sciences

Other

Collaborators

  • Poznan University of Medical Sciences

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 14, 2018
Registry last updated
Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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