Kefir on Bone Mineral Density and Bone Metabolism in Osteoporotic Patients
Short-term Effect of Kefir-fermented Milk Consumption on Bone Mineral Density and Bone Metabolism in Osteoporotic Patients
1 other identifier
interventional
69
0 countries
N/A
Brief Summary
In a controlled, parallel, double-blind intervention study over 6 months, the investigators investigated the effects of kefir-fermented milk (1,600 mg/kg) supplemented with calcium bicarbonate (CaCO3, 1,500 mg/kg) and bone metabolism in 40 osteoporosis patients, and compared them with CaCO3 alone without kefir supplements. Bone turnover markers were measured in fasting blood samples collected before therapy and at 1, 3, and 6 months. BMD values at the spine, total hip, and hip femoral neck were assessed by dual-energy x-ray absorptiometry (DXA) at baseline and at 6 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 26, 2014
CompletedFirst Posted
Study publicly available on registry
February 11, 2015
CompletedSeptember 1, 2015
August 1, 2015
1.7 years
September 26, 2014
August 30, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
bone mineral density and bone regeneration
3 months
Study Arms (2)
Kefir and CaCO3
EXPERIMENTALKefir were administered 1,600 mg kefir-fermented milk per day and an accompanying supplement of 1,500 mg CaCO3 for 6 months
Placebo and CaCO3
PLACEBO COMPARATORPlacebo and 1,500 mg of CaCO3 daily for 6 months
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of osteoporosis patients
You may not qualify if:
- Any previous use of parathyroid hormone or sodium fluoride, use of anabolic steroids or growth hormone within 6 months before trial entry or oral or intravenous systemic corticosteroids within 12 months, and any previous use of strontium.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Tu MY, Chen HL, Tung YT, Kao CC, Hu FC, Chen CM. Short-Term Effects of Kefir-Fermented Milk Consumption on Bone Mineral Density and Bone Metabolism in a Randomized Clinical Trial of Osteoporotic Patients. PLoS One. 2015 Dec 10;10(12):e0144231. doi: 10.1371/journal.pone.0144231. eCollection 2015.
PMID: 26655888DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ministry of Science and Technology
Study Record Dates
First Submitted
September 26, 2014
First Posted
February 11, 2015
Study Start
May 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
September 1, 2015
Record last verified: 2015-08