Professional Documents
Culture Documents
Formula de Pollo
Formula de Pollo
Objective: To evaluate the efficacy of a chicken-based diet for the treatment of persistent diarrhea in severely malnourished children.
Stud}" design: Prospective, randomized, double-blind study that compared a chickenbased diet with elemental (Vivonex) and soy (Nursoy) diets. Hospitalized children with
third-degree malnutrition and persistent diarrhea, aged 3 to 36 months, were included.
Diets were isocaloric and given nasogastrically at 150 ml/kg per day in progressively
increasing concentrations.
Results: Fifty-six children were included (18 received Vivonex, 19 Nursoy, 19 chicken). They had a mean age of 6.4 _+4.4 months, a mean weight of 3604 _+1232 gm, and a
mean weight-for-age percentage of 51.4% _+7.2%. Sixty-four percent had associated
conditions on admission to the hospital. Forty-one children (73.2%) were successfully
treated (13 Vivonex, 13 Nursoy, 15 chicken). There were no differences in diarrheal
outcomes, and all groups had significant weight gain. Failure was independent of the
diet and was associated with the presence of infection on admission. There was a significantly higher nitrogen balance in the children from the chicken group (358.2 _+13
mg/kg per day) than in those receiving Vivonex (226.6 +_61) or Nursoy (291.4 _+111.6;
p < 0.05) groups.
C o n c l u s i o n s : The chicken-based diet was as effective as Vivonex or Nursoy. It is well
tolerated, inexpensive, and widely available and thus represents an effective and inexpensive alternative to the treatment of severely malnourished children with persistent
diarrhea. (J Pediatr 1997;131:405-12)
From the Departnwat of Pediatric GaaO'oenterologyand Nutrition Hospital l@mtil de Mdrico Federico Gdme;4Mexico CitN
d/fexico.
Supported in part b2- the Applied Diarrheal Disease Research Project at Harvard University, by means of a
cooperative agreement with the U.S. Agency for International Development, and in part by National Institutes
of Health grant T32-DK 07703.
Submitted for publication April 3, 1996; accepted Dec. 17, 1996.
Reprint requests: Samuel Nurko, MD, Pediatric Gastroenterology, Children's Hospital, 300 Longwood Ave.,
Boston, MA 02115.
~Dr. Nurko is now in the Combined Program in Pediatric Gastroenterology and Nutrifon, Children's Hospital,
Boston, Mass.
Copyright 9 1997 by Mosby-Year Book, Inc.
0022-3476/97/$5.00 + 0 9/21/79985
405
NURKO ETAL.
Study Design
DIETS
METHODS
Patients
In this prospective, randomized, double-blind study a local chicken-based diet
was compared with both an elemental diet
(Vivonex Standard; Norwich Eaton) and
a soy-based formula (Nursoy; Wyeth
Laboratories) in the treatment of severely
malnourished hospitalized children with
PD.
406
The mainstay of therapy for PD and severe malnutrition at the Hospital Infantil
de Mgxico has been the elemental diet
Vivonex Standard. 5 Vivonex contains
crystalline amino acids, glucose and glucose oligosaccharides, a small amount of
highly purified safflower oil, electrolytes,
minerals, micronutrients, and vitamins, s'9
For use in children with PD, we and others have shown that Vivonex is effective if
it is given in progressively increasing concentrations, starting at 150 ml/kg per day
in a concentration that provides 47.8
kcal/dl (12.5% weight/volume) and advancing slowly by 2.5% per day to a maximum concentration of 85.6 kcal/dl
(22.5% weight/volume) s'9 (Table I).
Sodium chloride and potassium chloride
were also added to the formula to ensure
administration of sodium, 4 mEq/kg per
day, and potassium, 3 mEq/kg per day. 5
The chicken-based diet was designed with
the use of tables of food composition 19'20
and consists of easily available and simple
ingredients: cooking oil, boiled chicken
breast, table sugar, and minerals. To prepare the chicken-based diet, we calculated
the total volume needed per day (150
ml/kg). At the maximum concentration
(Table I) the following ingredients per
deciliter of diet were used: 8 gm boiled,
comminuted chicken breast; 3 ml vegetable cooking oil; and 10.5 gm table
sugar. After these components were
blended together, the following minerals
were added: 5 ml calcium gluconate (10%
solution, PISA), 2.7 ml of dibasic sodium
phosphate (PISA, dibasic sodium phosphate), and 1.7 ml of magnesium sulfate
(10% solution, PISA). Sodium chloride
(0.gN solution) to achieve 4 mEq of sodium per kilogram of body weight per day
and potassium chloride to achieve 3
mEq/kg/day were also added. Finally,
boiled water was added to achieve the
total volume required.
The soyformula used was Nursoy, which
contains soy protein, coconut, safflower
and soy oils, sucrose, minerals, and vitamins. All diets were prepared in the pedi-
NURKO ET AL.
PROTOCOL
Patients were randomly assigned to
treatment by using a table of random
numbers. Only the nutritionist who prepared the formula was aware of group assignment. The investigators, nurses, and
residents remained masked to the type of
diet because aluminum foil was used to
cover the formula bag and tubing.
On admission to the hospital, patients
were hydrated according to World Health
O r g a n i z a t i o n / U N I C E F guidelines with
the use of a standard glucose-electrolyte
solution. 21 Patients were then fasted
overnight. Hydration was maintained
during that time with intravenously administered fluids. The next morning the
assigned diet was started if the patient
was well hydrated and there were no
other contraindications to feeding. The
nasogastric tube was inserted by trained
nursing staff. The diet was started at the
lowest concentration at a volume of 150
ml/kg per day, and concentrations were
advanced every 48 hours. If no intolerance occurred, full concentration was
achieved by the ninth day (Table I). If
there was evidence of intolerance, the diet
concentration was either maintained or
decreased as follows: (1) It was kept unchanged if there was evidence of 2% or
3% positive reducing substances (before
or after hydrolysis) or if there was an increase in stool output of more than 50%
(>20 ml/kg). (2) It was reduced if Clinitest results showed 4% or if there was an
increase of 75% or more in the stool output (>20 m]/kg).
When full concentration of the diet was
CLINICAL PROCEDURES
Nude weight was obtained on admission and daily thereafter. The posthydration weight, obtained on the morning of
the start of the feedings, was considered
the baseline weight. Weights were obtained at the same time every morning
with an electronic scale (ScalesTronLx,
Wheaton, Ill.) and were accurate to at
least 10 gm. Recumbent length was obtained with a specially designed board on
admission, at the end of 2 weeks, and before discharge. All measurements were
obtained by trained nutritionists, and
their accuracy was validated before the
beginning of the study.
All patients had baseline laboratory values obtained at admission; laboratory
studies included complete blood cell
count, electrolyte concentrations, D-xylose concentration, stool and urine cultures, and stool tests for ova and parasites.
Blood culture specimens were obtained
only if indicated.
All intake and output were recorded.
Patients, both male and female, were
placed on metabolic beds or cots for separation of stool from urine. 5 To confirm
Successful separation of stool and urine in
girls, we performed a separate analysis
for all the variables associated with the
stool collection at the end of the study.
No differences between sexes were found
(data not shown), so all data were pooled.
A 72-hour nitrogen balance test was performed at the end of the second week,
starting 4 days after the maximum diet
concentration had been achieved. The
beginning and end of the stool collection
time were marked by the fecal excretion
of orally administered activated charcoal. s The nitrogen balance was measured by the micro Kjeldahl method. 22
Tests for p H and reducing and nonreducing substances in stool were performed
daily.
407
NURKO ET AL.
INFECTION ON ADMISSION OR
DURING HOSPITALIZATION
Statistical analysis
We calculated that a sample size of 20
children per group would be needed if we
408
RESULTS
Admission Characteristics
A total of 60 patients were initially enrolled in the study. Four were later excluded: two in the Vivonex group (one
with acquired immunodeficiency syndrome, one who died before initiation of
feedings), one in the Nursoy group (the
patient had primary renal insufficiency),
and one in the chicken group (the patient
had acute renal failure as a result of dehydration soon after admission). For the
other 56 patients, Vivonex was given to
NURKO ET AL.
Volume 13 I, Number 3
18, Nursoy to 19, and chicken to 19. Their
initial clinical and laboratory characteristics are Shown :in Table II. Sixty-four percent of the patients had associated conditions at the time of admission (Table II).
Fifty percent had a nongastrointestinal infection, and 14.3% had a gastrointestinal
infection.
There were no significant differences
between the three groups.
Table I I L Main outcome characteristics for the 41 patients who successfully completed
the stud;/
Outcome
A successful outcome was seen in 41 patients (73.2%): 13 (72.2%) with Vivonex,
13 (68.4%) with Nursoy, and 15 (78.9%)
with chicken (not significant). During the
study, 34 (60.7%) of the 56 patients had
some evidence of formula intolerance: 14
(77.8%) of the patients receiving Vivonex,
11 (57.9%) Nursoy, and 9 (47.4%) chicken (NS). The intolerance was transient in
19 (56%) of 34 patients. The other 15
(44%) (5 receiving Vivonex, 6 Nursoy,
and 4 chicken) had treatment failure. The
mean time from initiation of the diet to
failure was 85.6 72 hours (60.6 45.7
hours with Vivonex, 98.5 99.9 with
Nursoy, and 97.5 99.9 with chicken)
(NS). Intestinal pneumatosis developed
in 7.14% of the patients (2 patients receiving Vivonex, 1 Nursoy, and 1 chicken). One of the failures in the Nursoy
group was shown to be a result of allergy
to the formula.
Five patients (8.9%) died: two who had
been receiving Vivonex, 1 Nursoy, and 2
chicken (NS). The patients died of intestinal pneumatosis (2), central line-associated sepsis (2), and bacterial sepsis
(K[ebsfe/[apneanwn/ae)early in the hospital
course (1).
The other 10 patients with treatment
failure were successfully managed, and
their mean stay was 50 30 days. Total
parenteral nutrition was required in 7 of
the 10 patients, and 9 were eventually discharged home on a milk-containing diet
regimen. The other was discharged on a
soy- and milk-free diet regimen because of
allergy.
Diarrhea
The mean fecal output per kilogram of
body weight and the number of bowel
Nutritional Outcome
The mean number of total calories per
kilogram of body weight per day ingested
by each group after the full diet was tolerated was similar: 115.2 8.3, 111.3 9.1,
and 116.0 9.6 for the Vivonex, Nursoy,
and chicken groups, respectively. There
was a significant difference in the amount
Laboratory Tests
The serum albumin concentration decreased significantly in the Nursoy group
(from 3.5 0.6 to 3,l
grrdcll;p < 0.05),
whereas it did not change significantly in
the other groups: 3.3 0.6 to 3.2 0.5
409
NURKO ET AL.
SEPTEMBER 1 9 9 7
1.0
VIVONEX
"'. \ \
O.B
NUNSOY
\
.
CHICKEN
\\
-
0.6
\
DISCUSSION
\\
"0
~
0.4
\
m
oe-4
o,
~ ~
0.2
10
0.0
0
""
12
14
16
0.05)
Milk Tolerance Test
Intolerance was present in 7 patients
(17%): in none of the 13 patients in the
Vivonex group, in 3 (23.07%) of 13 in the
Nursoy group, and in 4 (21.1%) of 15 in
the chicken group. Those with milk intolerance had a lower admission weight
(2900.83 _+ 289.24 vs 3659.28 _+ 1258.91
gm; p < 0.004), a tendency to be younger
(3.91 +- 2.80 vs 6.64 + 4.1 months; p <
410
Risk Factors
There were significant differences (o <
0.05) between patients with treatment
success and those with treatment failure
with regard to the following admission
characteristics: albumin concentration
(3.2 _+0.6 vs 2.9 _+0,4 gm/dl), sodium concentration (138.4 _+ 6.2 vs 133.5 _+ 7.9
mmol/L), and the incidence of associated
infections (56.1% vs 86.7%). There were
also differences in stool output on the second (20.9 _+19.8 vs 47.4 +_33.9 ml/kg) and
third (16.7 +_ 16.5 vs 54.0 _+40.3 ml/kg)
days. No other significant differences
were found.
NURKO ET AL.
Volume 13 I, Number 3
given at a fixed volume and the caloric
density was advanced slowly. 5'6'9'2a'24
Sixty percent of children acquired some
signs of intolerance while the diet regimens were being advanced. These signs
were most likely related to carbohydrate
malabsorption, 12 and a good correlation
between fecal carbohydrates and total
fecal output has been shown. 25 O f the
three diets tested, Vivonex has a much
higher carbohydrate concentration (Table
I), mainly of oligosaecharides, which
probably accounts for the higher incidence of transient intolerance seen in
those patients. &25 Transient intolerance
was also seen in children receiving chicken or soy, which suggests that malnourished infants with PD frequently have
transient intolerance to other sugars. 25
Caution should be exercised in the treatment of those patients in whom increasing
stool outputs appear in the first and second day, because they may be at risk of
failure. In those children, a slower advancement of the dietary regimen may be
necessary.
A potential shortcoming of this study is
the difference in the macronutrient composition of the diets (Table I). In Vivonex, the
majority of the calories are provided by
carbohydrate and the protein content is
lower, &26"27providing only about 8% of
total calories. Previous studies confirm that
children receiving 6.70/0 of energy as protein achieved a slow compensatory
growth, 24"27and it has been shown recently that, in recovering malnourished infants,
there were no differences in growth when
formulas with 5.5%, 6.70/0, and 8.0% protein calories were compared. 28 Furthermore other studies have documented the
adequacy of Vivonex for growth and for
treatment of PD. 5'9 It is then possible that
the hydrolyzed amino acids are better absorbed. 5'9 This difference in protein content may partially explain why children on
the chicken-based diet regimen had a significantly higher nitrogen balance than
those receiving Vivonex.
The protein and caloric intakes were
similar in children receiving chicken or
soy feedings. The higher nitrogen balance
in those receiving chicken indicates that
chicken protein has a higher biologic
value than soy. Chicken has a low osmolarity, a better amino acid score, and a
higher degree of digestibility and bioavailability. 11'14'24We also found a significant
decrease in the serum albumin concentration in patients who received Nursoy despite a positive nitrogen balance. These
data suggest that the protein status and
lean body mass of malnourished patients
fed soy formulas may be deteriorating
slowly despite apparently adequate nitrogen retention. 29 It is therefore possible
that protein intake with Nursoy was inadequate to allow more rapid accretion of nitrogen at higher energy intakes. 29 Other
problems have also been associated with
the use of soy formulas in these patients.
Some authors have found that nearly 50%
of hospital-referred patients with PD do
not recover from diarrhea a week after the
introduction of a soy formula. 8 It has also
been suggested that soy-containing diets
may produce transient sensitivity and
subtle mucosal abnormalities in the intestinal mucosa of children with diarrhea,
with the potential for increasing the severity of their illness.16
Like Vivonex, 5 the chicken diet requires the addition of minerals. These
mineral additions make preparation suitable only in health care facilities, a factor
that does not represent a major obstacle
for severely malnourished children with
PD, who usually require hospitalization. 4
In the community the treatment of children with PD needs to include continued
feeding with locally available, inexpensive, and effective nutrients. I It is possible
that the chicken-based diet may be another alternative once the usual therapies
have failed.
All diets were administered continuously via nasogastric infusion, a method of
feeding that has been shown to have a
beneficial effect in control of diarrhea, nutrient absorption, nitrogen balance, and
weight gain in children with PD. <8'11'1a
Two main limitations of the nasogastric
route need to be mentioned. The technical
aspects of the placement and management
of the feedings requires specialized personnel and equipment, s More importantly the child has no control over the
amount of food that is being ingested,
help in the pe,formanee o/this study, in p~rtieula6 we thank Gina Toussaint, Dr. Liliana
Worona, Dr. Alejandra Consnelo, Rosaura
P~'ez, Sarah Arvizu, and Aloniea Covarrubias.
We are indebted to all the personnel of the
Applied Dialv'heal Disease Research Projectfor
rhea" support during the poformance of the
study. We also thank DI: Laurie Fishman and
DI: Alan Leiehtnerfor their o'itical reviewof the
manuscript andfor lheir helpful su~gestions.
REFERENCES
1. Bhutta ZA, Hendricks KM. Nutritional
management of persistent diarrhea in child-
411
NURKO ET AL.
2.
3.
4.
5.
6.
7.
8.
9.
10.
412
20.
21.
22.
25.
24.
25.
26.
27.
28.
29.