UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022859
Receipt number R000026340
Scientific Title Evaluation of the correlation between serum carnitine and constipation
Date of disclosure of the study information 2016/06/25
Last modified on 2017/07/18 18:20:17

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Basic information

Public title

Evaluation of the correlation between serum carnitine and constipation

Acronym

Evaluation of the correlation between serum carnitine and constipation

Scientific Title

Evaluation of the correlation between serum carnitine and constipation

Scientific Title:Acronym

Evaluation of the correlation between serum carnitine and constipation

Region

Japan


Condition

Condition

carnitine defeciensy,
constipatin\on

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Carnitine, which is acquired mostly through the diet, is an essential nutrient related to the mitochondrial transport of fatty acids. Carnitine deficiency causes a variety of symptoms in multiple organs due to mitochondrial dysfunction.
Most patients with severe motor and intellectual disabilities have epilepsy and are prescribed anti-epileptic drugs such as valproate sodium, which promotes the excretion of carnitine. Furthermore, as most of these patients cannot feed themselves, they receive enteral nutrition, which has less carnitine content than a normal diet. Use of valproate sodium and most enteral nutrition formulas for an extended time has been reported as a risk factor for carnitine deficiency. Therefore, patients with severe motor and intellectual disabilities are known to be at risk of deficiency of carnitine.
In our clinical practice we have treated many patients with severe motor and intellectual disabilities who have experienced relief from constipation after supplementation of carnitine. However, to our knowledge, there are few reports of studies designed to examine correlations between gastrointestinal dysmotility and deficiency of carnitine. Therefore, this study aimed to retrospectively review clinical data of patients with severe motor and intellectual disabilities in order to assess our suspicion of a correlation between constipation and carnitine deficiency.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

First, we examined the correlation between level of free carnitine and severity of constipation.
Second, we compared the constipation group with the non-constipation group in terms of age, sex, BMI, bed rest period (years), use of anti-epileptic drugs, use of valproate sodium, use of enteral nutrition, recurrent pulmonary infection (more than twice a year), presence of pressure ulcer, and results of blood tests for nutritional assessment (including serum levels of albumin, pre-albumin, total cholesterol, free carnitine, folic acid, and the trace elements Cu, Fe, Se, and Zn). Blood samples were collected in all cases during times when there were no observed inflammation reactions and no prescribed antibiotics. Carnitine levels also were obtained from patients without motor and intellectual disabilities who had severe chronic constipation requiring disimpaction with an enema on a daily basis.
Third, we compared the frequency of defecation and the form of feces before and after therapeutic supplementation with carnitine.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Supplementation with 10-50 mg/kg/day carnitine (P<0.001). No other changes of medication were made during the supplementation period.

Interventions/Control_2


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

2 years-old <=

Age-upper limit

45 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with severe motor and intellectual disabilities were defined as having an inability to move by themselves and IQ <35

Key exclusion criteria

The patients with infection or prescribed with antibiotics

Target sample size

27


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinya Murata

Organization

Hirakata City Hospital,

Division name

Department of Pediatrics,

Zip code


Address

2-14-1 Kinya-honmachi, Hirakata, Osaka 573-1013, Japan

TEL

072-847-2821

Email

wildwind1980@live.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinya Murata

Organization

Hirakata City Hospital,

Division name

Department of Pediatrics,

Zip code


Address

2-14-1 Kinya-honmachi, Hirakata, Osaka 573-1013, Japan

TEL

072-847-2821

Homepage URL


Email

wildwind1980@live.jp


Sponsor or person

Institute

Department of Pediatrics, Hirakata City Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Pediatrics, Hirakata City Hospital

Organization

Division

Category of Funding Organization

Local Government

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

2016 Year 06 Month 25 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2015 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2015 Year 01 Month 01 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

2016 Year 06 Month 23 Day

Last modified on

2017 Year 07 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026340


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name