Kefir on Bone Mineral Density and Bone Metabolism in Osteoporotic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02361372
Recruitment Status : Completed
First Posted : February 11, 2015
Last Update Posted : September 1, 2015
Information provided by (Responsible Party):
Min-Yu Tu, 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Other: Placebo Other: CaCO3 Other: Kefir Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Short-term Effect of Kefir-fermented Milk Consumption on Bone Mineral Density and Bone Metabolism in Osteoporotic Patients
Study Start Date : May 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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
Other: Kefir
Kefir daily for 6 months

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

Other: CaCO3
CaCO3 daily for 6 months

Primary Outcome Measures :
  1. bone mineral density and bone regeneration [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Min-Yu Tu, Ministry of Science and Technology, Ministry of Science and Technology, Taiwan Identifier: NCT02361372     History of Changes
Other Study ID Numbers: NSC-99-2324-B-005-017-CC1
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Carbonate
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents