- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: 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.
|
Sem intervenção: Control group
Participants do not receive any supplements, they stay with the original medication plan.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Changes from baseline systolic and diastolic blood pressure at 3 months
Prazo: Assessed at baseline and 3-month follow-up
|
measured by sphygmomanometer
|
Assessed at baseline and 3-month follow-up
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Changes from baseline concentration of hemoglobin A1c at 3 months
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Assessed at baseline and 3-month follow-up
|
measured by urinary test to obtain biochemistry profile
|
Assessed at baseline and 3-month follow-up
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2019781H
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .