Ratio of Dietary Calcium to Magnesium on Cardiovascular Risk

NCT04531267 | Unknown

• 1 other identifier: 2019781H
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

Although the epidemiological studies indicate how magnesium and calcium may interact to affect cardiovascular risk, current clinical trials have not elucidated the associations, particularly among hypertensive patients. To address the research gap, we have to examine how magnesium may influence cardiovascular profile of hypertensive patients via the modification of calcium homeostasis. Meanwhile, large-scale cohorts in China suggested keeping dietary calcium: magnesium ratio within 2.3 can reduce the risk of cardiovascular mortality. The results indicate the potential for individualized nutrition. This study will recruit uncontrolled hypertensive patients taking single drug and investigate whether calcium-magnesium combined supplements help to control their blood pressure. In standardized manner, subjects in the intervention group and the control group (each with 21 subjects) will be assessed for their dietary calcium and magnesium intake in the previous three months, so that researchers can provide calcium and/or magnesium supplements to maintain a calcium/magnesium ratio as 2.3. The effect of supplementation will be evaluated by the blood pressure changes in the 12th week of intervention.

Conditions

Hypertension; Nutritional and Metabolic Diseases; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

• Changes from baseline systolic and diastolic blood pressure at 3 months

  measured by sphygmomanometer

  Assessed at baseline and 3-month follow-up

Secondary Outcomes (6)

• Changes from baseline concentration of hemoglobin A1c at 3 months

  Assessed at baseline and 3-month follow-up

• Changes from baseline concentration of fasting glucose at 3 months

  Assessed at baseline and 3-month follow-up

• Changes from baseline concentration of fasting insulin at 3 months

  Assessed at baseline and 3-month follow-up

• Changes from baseline concentration of serum calcium and magnesium at 3 months

  Assessed at baseline and 3-month follow-up

• Changes from baseline concentration of urinary calcium and magnesium at 3 months

  Assessed at baseline and 3-month follow-up

Study Arms (2)

Individualized nutrition

ACTIVE COMPARATOR

Participants' diet will be assessed by food frequency questionnaire to obtain calcium and magnesium intake. Individualized dosage of dietary supplements will be provided to maintain a calcium/magnesium ratio as 2.3. Participants will stay with the original medication plan.

Dietary Supplement: Individualized dosage of calcium and magnesium

Control group

NO INTERVENTION

Participants do not receive any supplements, they stay with the original medication plan.

Interventions

Individualized dosage of calcium and magnesium DIETARY_SUPPLEMENT

Participants' diet will be assessed by food frequency questionnaire to obtain calcium and magnesium intake. Individualized dosage of dietary supplements will be provided to maintain a calcium/magnesium ratio as 2.3. Participants will stay with the original medication plan.

Individualized nutrition

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypertensive patients that received only one type of medication.
• Uncontrolled blood pressure: 140mmHg≤SBP≤149mmHg, 90mmHg≤DBP≤99mmHg.
• Able to sign informed consent and come to follow-up session by themselves.

You may not qualify if:

• Type 1 or 2 diabetic patients, or taking anti-diabetic drugs.
• Taking two types or above anti-hypertensive drugs
• Alanine transaminase or Aspartate Transaminase exceeding normal limits for 2 times or above.
• Acute myocardial infarction, heart failure or stroke in the last 6 months.
• Suffering from chronic gastrointestinal diseases
• Taking calcium or magnesium supplements in a regular basis (at least once per week) in the previous year
• In pregnancy or breastfeeding period, or planning to be pregnant
• Other serious diseases (e.g. cancer) that are not eligible for participation
• Participating in other studies.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

MeSH Terms

Conditions

Hypertension; Nutritional and Metabolic Diseases

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: August 28, 2020
• Study Start: January 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 28, 2020

Record last verified: 2020-05