The effect of high calcium vitamin D fortified milk drink on biochemical markers of bone turnover, vitamin D levels and parathyroid hormone levels in post-menopausal Chinese women.

Not Applicable

Completed

• Conditions: Bone loss; Musculoskeletal - Osteoporosis; Diet and Nutrition - Other diet and nutrition disorders; Public Health - Epidemiology

• Registration Number: ACTRN12612000329864
• Lead Sponsor: Marlena Kruger

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
serum C telopeptide of Type I collagen levels; analysed using electrochemiluminescence immunoassay using the Roche COBAS e411 system (Roche Diagnostics, Indianapolis, IN, USA).[0,2,8,12 weeks];Serum 25 (OH) D3 levels; analysed by electrochemiluminescence immunoassay using the Roche COBAS e411 system (Roche Diagnostics, Indianapolis, IN, USA).[0,2,8,12 weeks];Plasma Parathyroid Hormone levels analysed by electrochemiluminescence immunoassay using the Roche COBAS e411 system (Roche Diagnostics, Indianapolis, IN, USA).[0,2,8,12 weeks]

Secondary Outcome Measures

Name	Time	Method
Serum Interleukin 6 levels; R&D systems duoassay ELISA kits.[0,2,8,12 weeks];Plasma lipid levels; routine clinical laboratory analysis.[0, 12 weeks]