CClinicalTrials.gg
Sign In
CompletedNCT02361372Updated Sep 1, 2015

Kefir on Bone Mineral Density and Bone Metabolism in Osteoporotic Patients

An interventional study of Placebo and CaCO3 in Osteoporosis, sponsored by Ministry of Science and Technology, Taiwan. Completed. Open to participants aged 55 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-01.

Sponsored by Ministry of Science and Technology, Taiwan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
55 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoporosis

Browse trials for

03

Who can participate

Ages eligible
55 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Clinical diagnosis of osteoporosis patients

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
69 participants (actual)

Study arms

  • 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

  • Placebo comparator
    Placebo and CaCO3

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

    Other: Placebo · Other: CaCO3

Interventions

  • OtherPlacebo

    Placebo daily for 6 months

  • OtherCaCO3

    CaCO3 daily for 6 months

  • OtherKefir

    Kefir daily for 6 months

05

What researchers measure

Primary outcomes

  1. bone mineral density and bone regeneration

    Time frame: 3 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 26655888 ↗
08

Registry details

Key details

Study ID
NCT02361372
Lead sponsor
Ministry of Science and Technology, Taiwan
Responsible party
Min-Yu Tu (Ministry of Science and Technology, Ministry of Science and Technology, Taiwan) — Principal investigator
First posted
Feb 11, 2015
Start date
May 2010
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Sep 1, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Osteoporosis→

Other studies from this sponsor

Ministry of Science and Technology, Taiwan

Start the discussion