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

NCT03465462 | Completed

• 1 other identifier: 86/09
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional Disorder; Hypertension; Mineral Deficiency

Keywords

hypertension,; zinc; zinc supplementation; antihypertensive monotherapy; mineral status

Outcome Measures

Primary Outcomes (3)

• Serum zinc- stage I

  Serum zinc concentration in stage I of the trial

  At baseline

• Serum zinc- stage II

  Serum zinc concentration in stage II of the trial

  After 3 months

• Serum zinc- stage III

  Serum zinc concentration in stage III of the trial

  After 3 months and 30 days

Secondary Outcomes (48)

• 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

Study Arms (3)

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.

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.

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.

Dietary Supplement: group/arm S (supplementation group)

Interventions

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 C (control group)

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 D (diet group)

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.

group/arm S (supplementation group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poznan University of Life Sciences: lead
• Poznan University of Medical Sciences: collaborator

Study Sites (1)

Poznan University of Life Sciences

Poznan, 60-624, Poland

Location

MeSH Terms

Conditions

Nutrition Disorders; Hypertension

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Joanna Suliburska, Assoc. Prof.

  Poznan University of Life Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 14, 2018
• Study Start: January 2, 2016
• Primary Completion: December 29, 2016
• Study Completion: December 30, 2016
• Last Updated: March 14, 2018

Record last verified: 2018-03

Locations

PL (1)