RecruitingPhase 4ACTRN12617000697381

Calcium supplements and 24-hour blood pressure

Calcium supplements and 24-hour blood pressure: a randomised, cross-over, placebo-controlled trial in postmenopausal women


Sponsor

Sarah Bristow

Enrollment

50 participants

Start Date

Jan 17, 2018

Study Type

Interventional

Conditions

Summary

Many people take calcium supplements to improve their bone health. However, studies have shown that people who take calcium supplements long-term have a slightly higher chance of having a heart attack. How calcium supplements increase the risk of a heart attack is not known, but it might be through an effect on our blood pressure. In a recent study we found that when women took a calcium supplement in the morning; their blood pressure was higher for the next several hours than when they took a placebo (a pill containing no calcium). If this increase in blood pressure is repeated every time a calcium supplement is taken long-term it could be what is causing the increased risk of a heart attack. Calcium supplements are usually taken twice a day, in the morning and evening. The aim of this study is to find out how calcium supplements affect our blood pressure over a full day and night. To do this we need to measure blood pressure for 24 hours in women taking a morning and evening dose of a calcium supplement. We also want to find out if any effects of calcium supplements on blood pressure persist when people take them long-term. To do this we want to repeat the 24-hour measurement of blood pressure after women have taken a calcium supplement for 4 weeks. We would like to enrol 50 healthy women who have been through the menopause for at least 5 years. This study will compare two treatments: a. 0.5 grams of calcium as citrate (a calcium supplement) in the morning and evening b. A placebo (pills containing no calcium) in the morning and evening At each visit to our clinic participants will be given either the calcium supplement or the placebo along with a standardised breakfast meal. They will take their second dose of calcium or placebo pills that evening at home. During each visit to our clinic an ambulatory blood pressure monitor will be fitted on participants by study staff. This monitor will measure blood pressure every 30 minutes during the day and every 60 minutes during the night. Participants will be asked to keep an activity diary during the blood pressure monitoring periods. The first and second visits will be separated by at least 7 days during which participants will not be required to take any supplements. The second and third visits will be separated by 4 weeks during which half of the participants in the study will take the calcium supplement in the morning and evening every day and half will take the placebo. Participants will not know whether they are taking calcium or placebo at any of your visits or during the 4 weeks of supplementation. This study is awaiting ethical approval from the New Zealand Health and Disability Ethics Committee.


Eligibility

Sex: FemalesMin Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

Many older women take calcium supplements for bone health. However, some research suggests long-term calcium supplements may slightly increase the risk of heart attacks — possibly by raising blood pressure. This study monitors blood pressure over a full 24-hour period before and after taking calcium supplements to better understand this risk. You may be eligible if: - You are female - You have been through menopause for at least 5 years (or are over 55 years old) You may NOT be eligible if: - You have high blood pressure or are taking blood pressure medicines - You have heart disease, stroke, or diabetes - You have kidney or liver disease - You are currently taking calcium supplements (more than 100 mg per day) - You are taking vitamin D supplements above 2000 IU per day Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

0.5 grams of calcium as the citrate salt to be taken twice a day (once in the morning and once in the evening, 12 hours apart). The morning dose will taken at our clinic with a standardized breakfast

0.5 grams of calcium as the citrate salt to be taken twice a day (once in the morning and once in the evening, 12 hours apart). The morning dose will taken at our clinic with a standardized breakfast meal consisting of toast with spread, fruit and tea or coffee. The evening dose will be taken by participants at home. The intervention will be administered as oral tablets. The intervention will be taken by all participants at the first or second visit (in a cross-over design) with at least a 7 day washout period between visits. Those that receive the intervention at the second visit will continue to receive the intervention for a further 4 weeks. Adherence to the intervention will be monitored by tablet return.


Locations(1)

Auckland, New Zealand

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ACTRN12617000697381


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