NCT00503334

Brief Summary

The purpose of this pilot study is to investigate the effect of an oral nutritional supplement (preOP booster) versus placebo regarding metabolic criteria in patients undergoing elective pancreaticoduodenectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2007

Shorter than P25 for not_applicable

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

July 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

December 8, 2008

Status Verified

November 1, 2008

Enrollment Period

10 months

First QC Date

July 16, 2007

Last Update Submit

December 5, 2008

Conditions

Enteral Nutrition (Food for Special Medical Purposes)

Outcome Measures

Primary Outcomes (1)

  • laboratory measurements: total endogenous antioxidant capacity, free radicals, CRP;

    up to 30 days after surgery

Secondary Outcomes (1)

  • postoperative complications, pre- and postoperative discomfort (well-being), muscle strength at 7 days post-op, length of stay (hospital / ICU), ambulation time, gastro intestinal tolerance

    up to 30 days after surgery

Study Arms (2)

preOP booster

EXPERIMENTAL
Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes)

preOP booster placebo

PLACEBO COMPARATOR
Dietary Supplement: preOP booster (oral nutritional supplement, food for special medical purposes)

Interventions

preOP booster (oral nutritional supplement, food for special medical purposes)DIETARY_SUPPLEMENT

3x1 dosage pre-operatively

preOP boosterpreOP booster placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective pancreaticoduodenectomy

You may not qualify if:

  • Concomitant chemotherapy
  • Severe malnutrition (SGA score C)
  • Conditions affecting gastric emptying

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università Salute-Vita San Raffaele,

Milan, 20132, Italy

Location

MeSH Terms

Interventions

Dietary SupplementsFood

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Marco Braga, Prof MD

    Università Salute-Vita San Raffaele, Milan, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 18, 2007

Study Start

July 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

December 8, 2008

Record last verified: 2008-11

Locations

IT(1)