Kefir on Bone Mineral Density and Bone Metabolism in Osteoporotic Patients

Osteoporosis Clinical Trial

Official title:

Short-term Effect of Kefir-fermented Milk Consumption on Bone Mineral Density and Bone Metabolism in Osteoporotic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361372
• Other study ID #: NSC-99-2324-B-005-017-CC1
• Status: Completed
• Phase: N/A
• First received: September 26, 2014
• Last updated: August 30, 2015
• Start date: May 2010
• Est. completion date: January 2012

Study information

• Verified date: August 2015
• Source: Ministry of Science and Technology, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: National Science Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 70 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of osteoporosis patients

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Other:
• Placebo
Placebo daily for 6 months
• CaCO3
CaCO3 daily for 6 months
• Kefir
Kefir daily for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Science and Technology, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone mineral density and bone regeneration		3 months	Yes