Effectiveness of Supplementary Feeding During Infection Among Moderately Malnourished Children

Randomized Controlled Trial of an Outpatient Strategy of Ready to Use Supplementary Food (RUSF) Among Moderately Malnourished Children With Acute Infection

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00890695

Acronym

MODMAL

Enrollment

Registered

2009-04-30

Start date

2009-05-31

Completion date

2009-11-30

Last updated

2017-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Malnutrition

Keywords

supplementary feeding, moderate malnutrition, acute infection, developing country, children

Brief summary

The purpose of this study is to determine whether an outpatient-based strategy of short-term, ready to use supplementary food (RUSF) among moderately malnourished children with acute infections achieves greater improvement in anthropometric measurements of wasting than usual diet.

Detailed description

Under nutrition is a contributing factor to at least a third of child deaths. Whilst severe malnutrition has the highest mortality risk, most malnutrition-related deaths are thought to be related to mild-moderate malnutrition.This is because moderate malnutrition is common, it directly increases the risk of death from common infectious diseases and may progress to severe malnutrition. Malnutrition may arise from poverty, food insecurity or inadequate nutrition being offered, and may begin early in life. Malnutrition is exacerbated by the multiple effects of infectious diseases such as gastroenteritis, pneumonia, malaria or HIV. All these common infections are associated with net protein loss with diversion of essential amino acids to producing acute phase and immune response proteins. Fever is associated with an increased resting energy expenditure of 7 to 13% per degree Centigrade. Activation of inflammatory cascades also causes reduced appetite and loss of lean tissue and fat. Acute infection is therefore associated with growth faltering, resulting in a vicious cycle. Acute infection is therefore a potential target for intervention to interrupt the vicious cycle between malnutrition and infection in children. This study aims to evaluate a strategy of giving short-term RUSF as a supplement to usual diet at home, without daily observed feeding, administered through existing health services at Kilifi District Hospital, Kenya. RUSF has a very low moisture content and is essentially a lipid-enveloped paste, it is microbiologically stable with a long shelf life at tropical temperatures and preserves delicate micronutrients such as vitamin A.

Interventions

DIETARY_SUPPLEMENTReady to use supplementary food (RUSF)

It is a strategy of detection of moderate malnutrition and providing advice and short term provision of a standard formulation of ready to use supplementary food (RUSF) for 4 weeks with appropriate counseling on its use.The amount supplied will be based on the child's weight; 100kcal per kg per day which is equivalent to 25g RUSF per kg per day.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Open label randomised trial of nutrition products

Eligibility

Sex/Gender

ALL

Age

6 Months to 5 Years

Healthy volunteers

Inclusion criteria

* Age 6 months to 5 years * Mid-upper arm circumference (MUAC) less than 12.5 cm * Resident in the Kilifi demographic surveillance (DSS) area * Presentation with acute (\<5 days) illness including respiratory infection, malaria, diarrhoeal disease or other acute infection. * If admitted, admission of \<5 days, recruited at discharge.

Exclusion criteria

* Severe malnutrition (WHZ score \< -3 or Kwashiorkor) * Requiring admission to hospital in the opinion of clinician * Known allergy to maize, soya, sorghum, milk or any RUSF components. * Consent declined * Underlying condition precluding assessment or inclusion * Any other reason why the consenting investigator thinks it is not appropriate for them to take part.

Design outcomes

Primary

Measure	Time frame	Description
Weight for Height z Score at 4 Weeks	between enrolment and 4 weeks	The primary endpoint is weight for height z scores (WHZ), calculated from weight and height measures with reference to the WHO growth standards 2006. WHZ is a measure of wasting and acute malnutrition. A WHZ of zero is the median value of the reference population. Negative scores indicate undernutrition. Moderate and severe acute malnutrition are defined as WHZ\<-2 and \<-3 respectively. These correspond to 2 and 3 standard deviations below the reference median. Of all the anthropometric measures in regular use, WHZ and mid upper arm circumference (MUAC) have the strongest associations with infectious disease incidence and risk of death. WHZ is more appropriate than Weight for Age (WAZ), which is normally used in growth monitoring, because WAZ measures a combination of wasting and stunting (chronic malnutrition). Stunting is unlikely to be affected by short term intervention. WHZ is assessed by anthropometry, following WHO guidelines.

Secondary

Measure	Time frame
WHZ Score at 3 Months	between enrolment and 3 months
MUAC for Age Z Score at 3 Months	between enrolment and 4 weeks and at 3 months
Development of Severe Malnutrition (WHZ Score <-3 and/or Kwashiorkor)	at 4 weeks and 3 months
Anemia (Hb <9.3g/dl)	at 4 weeks
Hospital Admission or Death	from enrolment to 3 months

Countries

Kenya

Participant flow

Recruitment details

Recruitment was started on June 5 2009 and finished on October 8 2009. The study was terminated early because of an inadequate recruitment rate and because a donor-funded supplementary feeding programme targeting moderately malnourished children was started in September 2009.

Pre-assignment details

Of the 7,132 sick children aged 6 months to 5 years seen in outpatients during the study period, 190 with a mid upper arm circumference (MUAC) \<12.5cm were assessed for eligibility. Randomization was carried out on 65 children who were eligible and whose carers consented. 1 was withdrawn: weight for height Z score (WHZ) was found to be \<-3.

Participants by arm

Arm	Count
1 RUSF RUSF prescribed for the child for 4 weeks	31
2 Normal Diet normal diet arm	33
Total	64

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Protocol Violation	1	0

Baseline characteristics

Characteristic	2 Normal Diet	1 RUSF	Total
Age, Categorical <=18 years	33 Participants	31 Participants	64 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Age, Continuous	1.15 years STANDARD_DEVIATION 0.46	1.21 years STANDARD_DEVIATION 0.55	1.18 years STANDARD_DEVIATION 0.5
Region of Enrollment Kenya	33 participants	31 participants	64 participants
Sex: Female, Male Female	23 Participants	26 Participants	49 Participants
Sex: Female, Male Male	10 Participants	5 Participants	15 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 31	0 / 32
serious Total, serious adverse events	4 / 31	5 / 32

Outcome results

Primary

Weight for Height z Score at 4 Weeks

The primary endpoint is weight for height z scores (WHZ), calculated from weight and height measures with reference to the WHO growth standards 2006. WHZ is a measure of wasting and acute malnutrition. A WHZ of zero is the median value of the reference population. Negative scores indicate undernutrition. Moderate and severe acute malnutrition are defined as WHZ\<-2 and \<-3 respectively. These correspond to 2 and 3 standard deviations below the reference median. Of all the anthropometric measures in regular use, WHZ and mid upper arm circumference (MUAC) have the strongest associations with infectious disease incidence and risk of death. WHZ is more appropriate than Weight for Age (WAZ), which is normally used in growth monitoring, because WAZ measures a combination of wasting and stunting (chronic malnutrition). Stunting is unlikely to be affected by short term intervention. WHZ is assessed by anthropometry, following WHO guidelines.

Time frame: between enrolment and 4 weeks

Population: All participants recruited until trial was halted

Arm	Measure	Value (MEAN)
1 RUSF	Weight for Height z Score at 4 Weeks	-1.83 units on a scale
2 Normal Diet	Weight for Height z Score at 4 Weeks	-1.44 units on a scale

Secondary