Kefir on Bone Mineral Density and Bone Metabolism in Osteoporotic Patients

Not Applicable

Completed

• Conditions: Osteoporosis
• Interventions: Other: Kefir; Other: Placebo; Other: CaCO3

• Registration Number: NCT02361372
• Lead Sponsor: Ministry of Science and Technology, Taiwan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2015-02-06
• Study First Posted: 2015-02-11
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-30
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kefir and CaCO3	Kefir	Kefir 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	Placebo and 1,500 mg of CaCO3 daily for 6 months
Placebo and CaCO3	CaCO3	Placebo and 1,500 mg of CaCO3 daily for 6 months

Primary Outcome Measures

Name	Time	Method
bone mineral density and bone regeneration	3 months