None listed
Conditions
Brief summary
In Asia, osteoporosis is rapidly increasing amongst postmenopausal women with the subsequent increasing risk of hip fracture. Low calcium intake has been reported as one of the risk factors for osteoporosis amongst Asian women. In short-term studies, the measurement of biochemical markers to assess bone turnover offers an accepted means of determining the effect of a treatment or dietary supplement on bone metabolism prior to any significant change in actual bone density. In general, changes in levels of biochemical markers are well correlated with changes in bone density in post-menopausal women. The impact of a high calcium vitamin D fortified milk drink on biochemical markers of bone turnover has been recently assessed in two clinical trials. These were conducted in Indonesia and the Philippines, and clearly showed an immediate impact of the milk on reducing bone resorption and bone turnover in post-menopausal women. The purpose of the current study is to compare the effect of the high calcium milk drink with added vitamin D versus a placebo drink supplementation, on serum parathyroid hormone and blood mineral levels as well as markers of bone formation/ resorption in postmenopausal Chinese women over three months.
Interventions
Two glasses of milk (2x200ml) providing in total 900 mg calcium, 96 mg magnesium, 2.4 mg zinc and 6.4 microgram vit D to be consumed per day for 12 weeks.
Sponsors
Marlena Kruger
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
45 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Chinese women are to be recruited. 1. Subject is willing and able to provide written informed consent. 2. Ambulatory women who are at least 5 years postmenopausal defined as a cessation of menstruation, either due to spontaneous amenorrhea or surgical bi-lateral oorphorectomy. 3. Bone mineral density (BMD) higher than a T-score of -2.5 at both the total hip and spine (ie higher than 0.94 g/cm2 at the lumbar spine and 0.756 g/cm2 at the total hip) according to the GE lunar dual-X-Ray densitometry machine. 4. A Body Mass Index (BMI) of between 17 and 30.
Exclusion criteria
1. History of metabolic bone disease such as hyper- or hypoparathyroidism, Paget’s disease, osteomalacia or osteogenesis imperfecta, osteoporosis. (as defined by DEXA measurement or a history of osteoporotic fracture) 2. Any ongoing systemic disease that may affect bone mineral density. 3. Administration of any of the following drugs within 6 months before screening:- SERM, tibolone, anabolic steroids, glucocorticoids, systemic hormonal replacement therapy, calcitonin, calcitriol or vitamin D derivatives, other bone active agents including anti-convulsives, strontium ranelate, systemic ketoconazole. Androgens, ACTH, cinacalcet, aluminium, lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone agonists. 4. Regular use of medication that may affect bone mineral density. 5. A history of fracture in the last 6 months. 6. A history of chronic liver or renal function disease. 7. Abnormal liver function test or renal function tests at screening. 8. Diabetes Mellitus (based on either medical history or fasting glucose level at screening) 9. A history of milk allergy or intolerance to milk, or unable to confirm that they can take two glasses of milk per day. 10. Use of calcium, calcium fortified foods such as biscuits or juice, vitamin D, vitamin C and multivitamin supplements on a regular basis; use of anti-acids containing calcium on a regular basis and unwilling to stop these supplements or drug four weeks before going into the trial. 11. Baseline calcium intake of more than 500mg per day. 12. Currently consuming more than two units of alcohol per day or currently smoking cigarettes.
Outcome results
None listed