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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030881
Receipt No. R000035197
Scientific Title Dietary supplementation in patients following lumbar spine surgery: a randomized controlled trial
Date of disclosure of the study information 2018/01/18
Last modified on 2018/01/18

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Basic information
Public title Dietary supplementation in patients following lumbar spine surgery: a randomized controlled trial
Acronym Dietary supplementation in patients following lumbar spine surgery
Scientific Title Dietary supplementation in patients following lumbar spine surgery: a randomized controlled trial
Scientific Title:Acronym Dietary supplementation in patients following lumbar spine surgery
Region
Japan

Condition
Condition lumbar spinal stenosis
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of amino acid supplementation in patients treated with surgery for lumbar spinal stenosis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Zurich Claudication Questionnaire at 3 months after lumbar surgery
Key secondary outcomes body composition, gait speed, handgrip strength, albumin, Controlling Nutritional Status, Numerical Rating Scale, Japanese Orthopaedic Association Back Pain Evaluation Questionnaire, 36 item Short Form Survey

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intervention group
Twice-daily ingestion of amino acids supplementation for 3 weeks after spinal surgery (100kcal, protein 10g)
Postoperative rehabilitation for 3 weeks
Interventions/Control_2 Control group
Twice-daily ingestion of placebo (non amino acids) supplementation for 3 weeks after spinal surgery (100kcal, protein 0g )
Postoperative rehabilitation for 3 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patients treated with lumbar decompression
surgery or spinal fusion surgery for lumbar spinal stenosis
Key exclusion criteria More than 3 levels spinal fusion, chronic kidney disease, diabetes mellitus patients treated with insulin therapy, milk or soy allergy, BMI > 30kg/m2, cognitive impairment, a history of psychiatric illness, previous spine surgery, peripheral artery disorders
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mamoru Kawakami
Organization Wakayama Medical University Kihoku Hospital
Division name Spine Care Center
Zip code
Address 219 Myoji, Katsuragi-cho, Ito-gun, Wakayama 649-7113, Japan
TEL 0736-22-0066
Email kawakami@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masakazu Minetama
Organization Wakayama Medical University Kihoku Hospital
Division name Spine Care Center
Zip code
Address 219 Myoji, Katsuragi-cho, Ito-gun, Wakayama 649-7113, Japan
TEL 0736-22-0066
Homepage URL
Email masakazumasakazu910@hotmail.co.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization not applicable
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 01 Month 18 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 18 Day
Last modified on
2018 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035197

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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