HypertensionNCT04531267
Ratio of Dietary Calcium to Magnesium on Cardiovascular Risk
A study testing Individualized dosage of calcium and magnesium in people with Hypertension and Nutritional and Metabolic Diseases, run by Guangdong Provincial People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 79 years
- Conditions the study is for
- Hypertension, Nutritional and Metabolic Diseases, Cardiovascular Risk Factor
- What is being tested?
- Individualized dosage of calcium and magnesium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
About this study
Official title: Ratio of Dietary Calcium to Magnesium on Cardiovascular Risk of High-risk Population: an Intervention Study
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.
Read the detailed description
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.
- Being tested
- Individualized dosage of calcium and magnesium
- Medical subject headings
- Hypertension, Nutritional and Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized dosage of calcium and magnesiumDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline systolic and diastolic blood pressure at 3 months
measured by sphygmomanometer
Measured: Assessed at baseline and 3-month follow-up
Secondary outcomes (6)
Changes from baseline concentration of hemoglobin A1c at 3 months
measured by blood test to obtain biochemistry profile
Measured: Assessed at baseline and 3-month follow-up
Changes from baseline concentration of fasting glucose at 3 months
measured by blood test to obtain biochemistry profile
Measured: Assessed at baseline and 3-month follow-up
Changes from baseline concentration of fasting insulin at 3 months
measured by blood test to obtain biochemistry profile
Measured: Assessed at baseline and 3-month follow-up
Changes from baseline concentration of serum calcium and magnesium at 3 months
measured by blood test to obtain biochemistry profile
Measured: Assessed at baseline and 3-month follow-up
Changes from baseline concentration of urinary calcium and magnesium at 3 months
measured by urinary test to obtain biochemistry profile
Measured: Assessed at baseline and 3-month follow-up
Changes from baseline concentration of urinary creatine at 3 months
measured by urinary test to obtain biochemistry profile
Measured: Assessed at baseline and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study startJan 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531267
- Sponsor's protocol ID
- 2019781H
- Status last verified
- May 2020
- First submitted
- 16 Jun 2020
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ratio of Dietary Calcium to Magnesium on Cardiovascular Risk of High-risk Population: an Intervention Study
- ClinicalTrials.gov ID
- NCT04531267
- Acronym / sponsor ID
- 2019781H
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized nutrition | Active comparator | Dietary Supplement: Individualized dosage of calcium and magnesiumParticipants' 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. |
| Control group | No intervention | –Participants do not receive any supplements, they stay with the original medication plan. |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized dosage of calcium and magnesiumParticipants' 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 nutrition |
Primary outcome
Changes from baseline systolic and diastolic blood pressure at 3 months
Time frame: Assessed at baseline and 3-month follow-up
measured by sphygmomanometer
6 secondary outcomes
Changes from baseline concentration of hemoglobin A1c at 3 months
Time frame: Assessed at baseline and 3-month follow-up
Changes from baseline concentration of fasting glucose at 3 months
Time frame: Assessed at baseline and 3-month follow-up
Changes from baseline concentration of fasting insulin at 3 months
Time frame: Assessed at baseline and 3-month follow-up
Changes from baseline concentration of serum calcium and magnesium at 3 months
Time frame: Assessed at baseline and 3-month follow-up
Changes from baseline concentration of urinary calcium and magnesium at 3 months
Time frame: Assessed at baseline and 3-month follow-up
Changes from baseline concentration of urinary creatine at 3 months
Time frame: Assessed at baseline and 3-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized dosage of calcium and magnesium in people with Hypertension and Nutritional and Metabolic Diseases, run by Guangdong Provincial People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline systolic and diastolic blood pressure at 3 months (time frame: Assessed at baseline and 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.