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The Use of an Oral Mixture of Arginine, Glutamine and Beta-hydroxy-beta-methylbutyrate for Treatment of Pressure Ulcers

NCT ID: NCT03038490

Last Updated: 2017-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2020-03-31

Brief Summary

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To investigate whether an oral nutritional supplement of a mixture of arginine, glutamine and HMB for a maximum period of four weeks is more beneficial than the standard dietary approach to the healing of pressure ulcers, and to examine whether the use of it can reduce admissions and length of hospitalizations for these patients.

Detailed Description

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All patients would be assessed by a dietitian to ensure them receiving nutritional support of at least 30 kcal/kg/day and of at least 1.2 g/kg/day of protein regardless of feeding method. During the study period, vitamin C and zinc supplement would not be given. Nutritional supplement other than that provided by the dietitian to meet the energy and protein requirement would not be given. The pressure ulcers would be cared according to the "Basic nursing standards for patient care: Wound dressing - Version 5" published by the Hospital Authority Head Office.

The treatment group would also be given 2 Sackets of a mixture of arginine, glutamine and HMB (ABOUND) every day for a maximum period of 4 weeks, either orally or via enteral feeding.

Conditions

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Pressure Ulcers Stage III Pressure Ulcer, Stage IV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group

The treatment group would be given 2 Sackets of an oral mixture of arginine, glutamine and HMB (ABOUND) every day for a maximum period of 4 weeks, either orally or via enteral feeding.

Group Type EXPERIMENTAL

ABOUND

Intervention Type DIETARY_SUPPLEMENT

an oral mixture of arginine, glutamine and beta-hydroxy-beta-methylbutyrate

Control group

All patients would be assessed by a dietitian to ensure them receiving nutritional support of at least 30 kcal/kg/day and of at least 1.2 g/kg/day of protein regardless of feeding method. During the study period, vitamin C and zinc supplement would not be given.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ABOUND

an oral mixture of arginine, glutamine and beta-hydroxy-beta-methylbutyrate

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Inpatients of medical and geriatric wards of OLMH and WTSH
2. Aged 18 and older with stage III - IV lesions
3. Patients fed orally or through feeding tubes were included

Exclusion Criteria

1. Patients with history of using the nutritional supplement (ABOUND) in previous three months
2. Patients with cellulitis, wounds with purulent discharge or osteomyelitis or sepsis
3. Patients requiring protein restriction
4. Patients with poorly controlled diabetes mellitus (latest HbA1C \> 8.5) (healing process may be affected
5. Patients under palliative care
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wong Tai Sin Hospital

UNKNOWN

Sponsor Role collaborator

Our Lady of Maryknoll Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lo Kwok Man

Associate Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Our Lady of Maryknoll Hospital

Wong Tai Sin, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Kwok Man Lo, FHKAM (Med)

Role: CONTACT

Email: [email protected]

Ka Ying Doris Miu, FHKAM (Med)

Role: CONTACT

References

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Cereda E, Gini A, Pedrolli C, Vanotti A. Disease-specific, versus standard, nutritional support for the treatment of pressure ulcers in institutionalized older adults: a randomized controlled trial. J Am Geriatr Soc. 2009 Aug;57(8):1395-402. doi: 10.1111/j.1532-5415.2009.02351.x. Epub 2009 Jun 25.

Reference Type BACKGROUND
PMID: 19563522 (View on PubMed)

Wong A, Chew A, Wang CM, Ong L, Zhang SH, Young S. The use of a specialised amino acid mixture for pressure ulcers: a placebo-controlled trial. J Wound Care. 2014 May;23(5):259-60, 262-4, 266-9. doi: 10.12968/jowc.2014.23.5.259.

Reference Type BACKGROUND
PMID: 24810310 (View on PubMed)

Cereda E, Klersy C, Serioli M, Crespi A, D'Andrea F; OligoElement Sore Trial Study Group. A nutritional formula enriched with arginine, zinc, and antioxidants for the healing of pressure ulcers: a randomized trial. Ann Intern Med. 2015 Feb 3;162(3):167-74. doi: 10.7326/M14-0696.

Reference Type BACKGROUND
PMID: 25643304 (View on PubMed)

Other Identifiers

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KW/FR-16-167(104-04)

Identifier Type: -

Identifier Source: org_study_id