The Influence of Hypotensive Drugs on Mineral Status in Experimental and Clinical Studies
Condition: Nutritional Disorder; Hypertension; Mineral Deficiency
MeSH terms: Hypertension; Nutrition Disorders
Study type: Interventional

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.
    

Intervention name(s): group/arm C (control group); group/arm D (diet group); group/arm S (supplementation group)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Treatment
Keywords: hypertension,; zinc; zinc supplementation; antihypertensive monotherapy; mineral status