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Trial registered on ANZCTR


Trial ID
ACTRN12612000329864
Ethics application status
Approved
Date submitted
21/03/2012
Date registered
22/03/2012
Date last updated
22/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 280177 0
Nil
Universal Trial Number (UTN)
Trial acronym
Pakn
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone loss 286111 0
Condition category
Condition code
Musculoskeletal 286304 286304 0 0
Osteoporosis
Diet and Nutrition 286305 286305 0 0
Other diet and nutrition disorders
Public Health 286306 286306 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 284506 0
Prevention
Comparator / control treatment
Rice-based placebo drink
Control group
Placebo

Outcomes
Primary outcome [1] 286775 0
serum C telopeptide of Type I collagen levels; analysed using electrochemiluminescence immunoassay using the Roche COBAS e411 system (Roche Diagnostics, Indianapolis, IN, USA).
Timepoint [1] 286775 0
0,2,8,12 weeks
Primary outcome [2] 286776 0
Serum 25 (OH) D3 levels; analysed by electrochemiluminescence immunoassay using the Roche COBAS e411 system (Roche Diagnostics, Indianapolis, IN, USA).
Timepoint [2] 286776 0
0,2,8,12 weeks
Primary outcome [3] 286777 0
Plasma Parathyroid Hormone levels analysed by electrochemiluminescence immunoassay using the Roche COBAS e411 system (Roche Diagnostics, Indianapolis, IN, USA).
Timepoint [3] 286777 0
0,2,8,12 weeks
Secondary outcome [1] 296638 0
Serum Interleukin 6 levels; R&D systems duoassay ELISA kits.
Timepoint [1] 296638 0
0,2,8,12 weeks
Secondary outcome [2] 296639 0
Plasma lipid levels; routine clinical laboratory analysis.
Timepoint [2] 296639 0
0, 12 weeks

Eligibility
Key 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.
Minimum age
45 Years
Maximum age
65 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Screening: Excisting data base was screened for eligible women. 130 women were identified and subjected to bone density measurements as well as blood tests. Of these 100 were eligible. 63 were randomised using central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation in Minitab version 15.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4209 0
China
State/province [1] 4209 0
Beijing

Funding & Sponsors
Funding source category [1] 284931 0
Commercial sector/Industry
Name [1] 284931 0
Fonterra Brands AME Ltd
Address [1] 284931 0
Fonterra Co-operative Group Limited
Private Bag 92032, 9 Princes Street, Auckland, 1010
Country [1] 284931 0
New Zealand
Primary sponsor type
Individual
Name
Marlena Kruger
Address
IFNHH, Massey University, Private Bag 11222, Palmerston North, 4442
Country
New Zealand
Secondary sponsor category [1] 283810 0
Other Collaborative groups
Name [1] 283810 0
Center for Clinical and Basic Research
Address [1] 283810 0
1st Floor Tower C, No. 29 Life Science Park

Road Changping District, Beijing 102206 P.R
Country [1] 283810 0
China
Other collaborator category [1] 260643 0
Individual
Name [1] 260643 0
Dr Edith Lau
Address [1] 260643 0
Center for Health and Medical Research, Hong Kong 6 floor,

Tower ll, New World Tower, 18 Queen's Road central Hong Kong
Country [1] 260643 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286935 0
Beijing Friendship Hospital
Ethics committee address [1] 286935 0
Ethics committee country [1] 286935 0
China
Date submitted for ethics approval [1] 286935 0
06/12/2010
Approval date [1] 286935 0
29/12/2010
Ethics approval number [1] 286935 0
Approval number: (2010)-040.

Summary
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.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 33948 0
Address 33948 0
Country 33948 0
Phone 33948 0
Fax 33948 0
Email 33948 0
Contact person for public queries
Name 17195 0
Marlena Kruger
Address 17195 0
IFNHH, Massey University, Private Bag 11222, Palmerston North 4442
Country 17195 0
New Zealand
Phone 17195 0
+6463505905
Fax 17195 0
+6463505446
Email 17195 0
m.c.kruger@massey.ac.nz
Contact person for scientific queries
Name 8123 0
Marlena Kruger
Address 8123 0
IFNHH, Massey University, Private Bag 11222, Palmerston North 4442
Country 8123 0
New Zealand
Phone 8123 0
+6463505905
Fax 8123 0
+6463505446
Email 8123 0
m.c.kruger@massey.ac.nz