The Influence of Hypotensive Drugs on Zinc, Copper and Iron Status in Experimental and Clinical Studies.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Serum zinc- stage I
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: group/arm C (control group) (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.
干预措施: group/arm D (diet group) (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.
干预措施: group/arm S (supplementation group) (Dietary Supplement)
结局指标
主要结局
Serum zinc- stage I
时间窗: At baseline
Serum zinc concentration in stage I of the trial
Serum zinc- stage II
时间窗: After 3 months
Serum zinc concentration in stage II of the trial
Serum zinc- stage III
时间窗: After 3 months and 30 days
Serum zinc concentration in stage III of the trial
次要结局
- Serum copper- stage III(After 3 months and 30 days)
- Body mass- stage I(At baseline)
- Body mass- stage II(After 3 months)
- Body mass- stage III(After 3 months and 30 days)
- Body height- stage I(At baseline)
- Body height- stage II(After 3 months)
- Body height- stage III(After 3 months and 30 days)
- Blood pressure- stage I(At baseline)
- Blood pressure- stage II(After 3 months)
- Blood pressure- stage III(After 3 months and 30 days)
- Erythrocytes zinc- stage I(At baseline)
- Erythrocytes zinc- stage II(After 3 months)
- Erythrocytes zinc- stage III(After 3 months and 30 days)
- Urine zinc- stage I(At baseline)
- Urine zinc- stage II(After 3 months)
- Urine zinc- stage III(After 3 months and 30 days)
- Hair zinc- stage I(At baseline)
- Hair zinc- stage II(After 3 months)
- Hair zinc- stage III(After 3 months and 30 days)
- Serum iron- stage I(At baseline)
- Serum iron- stage II(After 3 months)
- Serum iron- stage III(After 3 months and 30 days)
- Erythrocytes iron- stage I(At baseline)
- Erythrocytes iron- stage II(After 3 months)
- Erythrocytes iron- stage III(After 3 months and 30 days)
- Urine iron- stage I(At baseline)
- Urine iron- stage II(After 3 months)
- Urine iron- stage III(After 3 months and 30 days)
- Hair iron- stage I(At baseline)
- Hair iron- stage II(After 3 months)
- Hair iron- stage III(After 3 months and 30 days)
- Serum copper- stage I(At baseline)
- Serum copper- stage II(After 3 months)
- Erythrocytes copper- stage I(At baseline)
- Erythrocytes copper- stage II(After 3 months)
- Erythrocytes copper- stage III(After 3 months and 30 days)
- Urine copper- stage I(At baseline)
- Urine copper- stage II(After 3 months)
- Urine copper- stage III(After 3 months and 30 days)
- Hair copper- stage I(At baseline)
- Hair copper- stage II(After 3 months)
- Hair copper- stage III(After 3 months and 30 days)
- Glucose- stage I(At baseline)
- Glucose- stage II(After 3 months)
- Glucose- stage III(After 3 months and 30 days)
- C-reactive protein- stage I(At baseline)
- C-reactive protein- stage II(After 3 months)
- C-reactive protein- stage III(After 3 months and 30 days)
研究者
Joanna Suliburska
Associate Professor
Poznan University of Life Sciences