MalnutritionMODMALNCT00890695
Effectiveness of Supplementary Feeding During Infection Among Moderately Malnourished Children
A study testing Ready to use supplementary food (RUSF) in people with Malnutrition and Infection, run by University of Oxford at 2 sites in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Malnutrition, Infection
- What is being tested?
- Ready to use supplementary food (RUSF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesKenya
- Study dates
- May 2009to Nov 2009
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Kenya2 sites
Kemri Wellcome Trust Research Programme
Kilifi, Coast Province, 80108
Kilifi District Hospital- OPD
Kilifi, Coast, 80108
About this study
Official title: Randomized Controlled Trial of an Outpatient Strategy of Ready to Use Supplementary Food (RUSF) Among Moderately Malnourished Children With Acute Infection
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.
Read the 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.
- Conditions
- Malnutrition, Infection
- Being tested
- Ready to use supplementary food (RUSF)
- Keywords
- supplementary feeding, moderate malnutrition, acute infection, developing country, children
- Medical subject headings
- Malnutrition, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready to use supplementary food (RUSF)Dietary supplement
Also called 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 group | Role | What they receive |
|---|---|---|
| Ready to use supplementary food (RUSF) | Active comparator | The RUSF intervention consists of a food paste made of maize, soya, sorghum, vegetable oil, sugar, dried skim milk and vitamin/mineral premix, prepared by VALID Nutrition in collaboration with Insta Products, Kenya in accordance with composition specified by the latest WHO expert consultation in 2008. Children in the intervention arm receive 4 weeks supply of RUSF. The amount supplied is based on the child's weight to give energy supplement of 100kcal per kg per day, equivalent to 25g RUSF per kg per day. Receives: Dietary Supplement: Ready to use supplementary food (RUSF) |
| Normal diet (standard of care) | No intervention | For equity, parents or guardians of children in the usual diet arm will be given 2 bags of maize meal(4Kg) for family consumption instead of RUSF. All parents and carers in both arms will also receive standard nutritional advice as specified in the current WHO IMCI handbook. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: between enrolment and 4 weeks
Secondary outcomes (5)
WHZ Score at 3 Months
Measured: between enrolment and 3 months
MUAC for Age Z Score at 3 Months
Measured: between enrolment and 4 weeks and at 3 months
Development of Severe Malnutrition (WHZ Score <-3 and/or Kwashiorkor)
Measured: at 4 weeks and 3 months
Anemia (Hb <9.3g/dl)
Measured: at 4 weeks
Hospital Admission or Death
Measured: from enrolment to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2009
- Study completionNov 2009
Why it stopped: New provision of supplementary feeds for moderately malnourished children
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label randomised trial of nutrition products
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Berkley, University of Oxford
- Investigators
- James A Berkley, Principal investigator, KEMRI-Wellcome Trust Collaborative Research Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890695
- Sponsor's protocol ID
- SSC 1415
- Acronym
- MODMAL
- Status last verified
- Jun 2017
- First submitted
- 29 Apr 2009
- Last updated
- 14 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No