A randomised cross-over trial to examine the effects of calcium citrate on blood calcium levels, blood coagulation and blood pressure in normal postmenopausal wome

Not Applicable

Recruiting

• Conditions: Cardiovascular disease; Diet and Nutrition - Other diet and nutrition disorders; Cardiovascular - Hypertension; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12614000865617
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Female, postmenopausal 5 years or more (menopause defined as at least 12 months since last period in a woman aged > 45 yrs with intact uterus, or serum oestradiol < 100 pmol/l with FSH > 50 IU/l in younger or hysterectomised women).

Exclusion Criteria

Current smoker, current use of Warfarin, aspirin or other blood thinning medications, diabetes, current use of blood pressure medication, past history of coronary heart disease, cerebrovascular disease or peripheral vascular disease, renal impairment (serum creatinine >0.15 mmol/L), chronic liver disease, untreated hypothyroidism or hyperthyroidism, concurrent major systemic illness, including malignancy, active major gastrointestinal disease, metabolic bone diseases, or serum ALP >normal, primary hyperparathyroidism, calcium supplements: those consistently using 500 mg/day or more need to be off calcium supplements for 6 months before entering the study; doses <100 mg/day can be continued during the study; doses between 100 and 499 mg/day require intermediate times of withdrawal prior to study entry, current or expected use of oral glucocorticoid drugs during the trial period, current or past use of bisphosphonate therapy in the preceding 2 years, use of hormone replacement therapy within the last 12 months, use of other medication known to cause osteoporosis or interfere with bone metabolism, calciferol supplements > 2000 IU/day (lower doses can be continued during the study).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in systolic and diastolic blood pressure as measured by an automatic sphygmomanometer[2, 4 and 6 hours after each intervention is ingested];Change in R-time (time to clot initiation) as measured by thromboelastography using a Thromboelastograph (Haemoscope, Stokie, IL)[2, 4, 6 hours after each intervention is ingested];Change in other measures of blood coagulation (K-time, alpha angle, maximum ampltiude and coagulation index) as measured by thromboelastography using a Thromboelastograph (Haemoscope, Stokie, IL)[2, 4 and 6 hours after each intervention is ingested]

Secondary Outcome Measures

Name	Time	Method
Change in serum ionised and total calcium as measured by serum assay[2, 4 and 6 hours after each intervention is ingested]