NCT01928134

Brief Summary

This study used the generally recognized as safe (GRAS) grade of Bacillus subtilis natto to produce Vitamin K2, Menaquinone-7(MK-7), via fermentation, for functional evaluation. There are four major objectives for this study: (1) bioavailability of calcium; (2) evaluation of bone density improvement; (3) evaluation of blood-vessel calcification and sclerosis improvement; (4) safety evaluation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2013

Completed
Last Updated

August 23, 2013

Status Verified

August 1, 2013

Enrollment Period

7 months

First QC Date

August 19, 2013

Last Update Submit

August 22, 2013

Conditions

Healthy

Keywords

Vitamin K2Vitamin D3Bioavailability of calciumvolunteersMennon-pregnant womentwenty years of age

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Serum Calcium

    at 4 hours after intake

Secondary Outcomes (1)

  • Change from baseline in urine calcium/creatinine ratio

    at 4 hours after intake

Other Outcomes (1)

  • Change from baseline in serum Parathyroid hormone(PTH)

    at 4 hour after intake

Study Arms (2)

A

EXPERIMENTAL

Vit K2+ Vit D3+ calcium carbonate (CaCO3)

Dietary Supplement: Vit K2+ Vit D3+ calcium carbonate (CaCO3)

B

ACTIVE COMPARATOR

Vit K2+CaCO3

Dietary Supplement: Vit K2+CaCO3

Interventions

Vit K2+ Vit D3+ calcium carbonate (CaCO3)DIETARY_SUPPLEMENT
A
Vit K2+CaCO3DIETARY_SUPPLEMENT
B

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and non-pregnant women who are at least 20 years and under 75 years of age; and
  • Female subjects cannot be pregnant or breast feeding.
  • Patients who are, in the opinion of the Investigator, able to comply with the requirements of the study; and
  • Patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving study medication.

You may not qualify if:

  • Women who are pregnant, as determined by a urine pregnancy test, or breast-feeding.
  • Presence or history of congestive heart failure (NYHA class III/IV) within the prior 12 weeks.
  • Recent myocardial infarction (within the prior 12 weeks).
  • Unstable angina pectoris.
  • Known or suspected renal insufficiency defined as creatinine\>1.5mg/dl.
  • Known or suspected hepatic insufficiency defined as abnormal liver function tests (GOT/GPT) \>3x upper normal limit (i.e., 120 U/l).
  • Known hypomotility syndrome: (such as hypothyroidism or scleroderma).
  • Recent major trauma within the prior 12 weeks.
  • Recent surgery requiring anesthesia including coronary artery bypass graft (within 12 weeks).
  • Recent hospitalization (within 12 weeks)
  • Uncontrolled hypertension (defined as a systolic blood pressure\>180mmHg or a diastolic blood pressure \>105mmHg).
  • Uncontrolled hyperlipidemia (defined as total cholesterol\>240mg/dL or triglyceride \>200mg/dL).
  • Uncontrolled diabetes (defined as HbA1c\>7%).
  • Cigarette smoker (\>=1/day).
  • Acute infection requiring current antibiotic therapy.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhua Christian Hospital

Changhua, Taiwan, 500, Taiwan

Location

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Multiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Officials

  • Shih-Li Su, MD

    Changhua Christian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician of Section of Endocrinology and Metabolism

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 23, 2013

Study Start

April 1, 2011

Primary Completion

November 1, 2011

Study Completion

February 1, 2012

Last Updated

August 23, 2013

Record last verified: 2013-08

Locations

TW(1)