Kefir on Bone Mineral Density and Bone Metabolism in Osteoporotic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Kefir and CaCO3

Kefir were administered 1,600 mg kefir-fermented milk per day and an accompanying supplement of 1,500 mg CaCO3 for 6 months

Group Type EXPERIMENTAL

Kefir

Intervention Type OTHER

Kefir daily for 6 months

Placebo and CaCO3

Placebo and 1,500 mg of CaCO3 daily for 6 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo daily for 6 months

CaCO3

Intervention Type OTHER

CaCO3 daily for 6 months

Interventions

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Placebo

Placebo daily for 6 months

Intervention Type OTHER

CaCO3

CaCO3 daily for 6 months

Intervention Type OTHER

Kefir

Kefir daily for 6 months

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes