- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04531267
Ratio of Dietary Calcium to Magnesium on Cardiovascular Risk
Ratio of Dietary Calcium to Magnesium on Cardiovascular Risk of High-risk Population: an Intervention Study
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
In 2015, the prevalence of hypertension in Chinese adults was 25.2%, which can be translated into 25 million people with hypertension in Guangdong Province. Hypertension is also related to narrowing and occlusion of the cardiovascular vessels. In China, coronary heart disease and stroke are the main causes of death in many provinces, and the early prevention of cardiovascular disease risk in patients with hypertension has become a research direction dedicated to the whole population. Magnesium is the second most abundant intracellular ion in the body, which can regulate vascular tone, and together with calcium leads to changes in vascular smooth muscle tone and contractility. Magnesium deficiency is associated with oxidative stress, inflammation, endothelial dysfunction, platelet aggregation, insulin resistance, and hyperglycemia; in the long run, dietary magnesium deficiency also increases the risk of developing metabolic syndrome, type 2 diabetes, cardiovascular disease, and cancer. However, the impact of nutrients on health is affected by different dietary factors. Calcium and magnesium share different ion receptors or channels, including Calcium-sensing receptor (modulates parathyroid hormone levels, thereby increasing the production of vitamin D), as well as TRPM6 and TRPM7 (modulates the absorption of calcium and magnesium ions). In a large meta-analysis, there is also evidence that calcium supplements may reduce blood pressure in healthy people.
In addition, in epidemiological studies, we can see the interactive relationship between calcium and magnesium. In the American population, when the ratio of calcium to magnesium is <2.8, dietary intake of calcium and magnesium can reduce the risk of colorectal adenoma. However, when the ratio of calcium to magnesium is too low (<2.0), it may also cause adverse effects. According to data from more than 130,000 people in the Shanghai Women's Health Study and the Shanghai Men's Health Study, the median calcium-magnesium ratio (1.7) in the Chinese population is much lower than the calcium-magnesium ratio (3.0) in the US population. When the calcium-magnesium ratio is > 1.7, calcium and magnesium intake can reduce the mortality of cardiovascular disease; but when the calcium-magnesium ratio is <1.7, magnesium intake increases the risk of cardiovascular death in women. Although the interaction between magnesium and calcium can influence cardiovascular risk in epidemiological studies, the current clinical evidence have not fully verified the relationship, especially among hypertensive patients . To substantiate the research findings, it is necessary to explore how calcium-magnesium intervention can improve the cardiovascular risk factors of hypertensive patients. In addition, personalized nutrition intervention is also a research direction to be explored. Unlike the unified dosage in the past, it may be more important to formulate supplements according to individual dietary habits. In 2018, Vanderbilt University's team conducted a clinical trial among 180 healthy adults with personalized magnesium supplements and examined on the effects of blood vitamin D. They adjusted the dose of supplements according to the calcium-magnesium ratio in the diet at baseline to achieve a calcium-magnesium ratio of 2.3, and tested changes in various types of vitamin D in the blood. They found that the effect of magnesium supplements on vitamin D levels varied according to the baseline 25(OH)D concentration. When 25(OH)D levels are higher, magnesium supplements reduced the levels of 25(OH)D3 and 24,25(OH)2D3. But when 25(OH)D is low, magnesium supplements increased the level of 25(OH)D3. This is the first study to use baseline dietary intakes for personalized nutrition interventions, but they have not explored whether interventions can affect cardiovascular risk factors in hypertensive patients. More randomized trials are needed to verify the efficacy of intervention, especially in high-risk populations.
To answer the above questions, this study is a randomized trial to ensure that the highest level of evidence is obtained and will recruit hypertensive patients in Guangdong Provincial People's Hospital. The intervention and control group have the same number of people.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Individualized nutrition
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.
|
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.
|
Ingen indgriben: Control group
Participants do not receive any supplements, they stay with the original medication plan.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Changes from baseline systolic and diastolic blood pressure at 3 months
Tidsramme: Assessed at baseline and 3-month follow-up
|
measured by sphygmomanometer
|
Assessed at baseline and 3-month follow-up
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Changes from baseline concentration of hemoglobin A1c at 3 months
Tidsramme: Assessed at baseline and 3-month follow-up
|
measured by blood test to obtain biochemistry profile
|
Assessed at baseline and 3-month follow-up
|
Changes from baseline concentration of fasting glucose at 3 months
Tidsramme: Assessed at baseline and 3-month follow-up
|
measured by blood test to obtain biochemistry profile
|
Assessed at baseline and 3-month follow-up
|
Changes from baseline concentration of fasting insulin at 3 months
Tidsramme: Assessed at baseline and 3-month follow-up
|
measured by blood test to obtain biochemistry profile
|
Assessed at baseline and 3-month follow-up
|
Changes from baseline concentration of serum calcium and magnesium at 3 months
Tidsramme: Assessed at baseline and 3-month follow-up
|
measured by blood test to obtain biochemistry profile
|
Assessed at baseline and 3-month follow-up
|
Changes from baseline concentration of urinary calcium and magnesium at 3 months
Tidsramme: Assessed at baseline and 3-month follow-up
|
measured by urinary test to obtain biochemistry profile
|
Assessed at baseline and 3-month follow-up
|
Changes from baseline concentration of urinary creatine at 3 months
Tidsramme: Assessed at baseline and 3-month follow-up
|
measured by urinary test to obtain biochemistry profile
|
Assessed at baseline and 3-month follow-up
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2019781H
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Kliniske forsøg med Individualized dosage of calcium and magnesium
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