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New provision of supplementary feeds for moderately malnourished children
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ready to use supplementary food (RUSF) | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | between enrolment and 4 weeks |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James A Berkley | KEMRI-Wellcome Trust Collaborative Research Program | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kemri Wellcome Trust Research Programme | Kilifi | Coast Province | 80108 | Kenya | ||
| Kilifi District Hospital- OPD |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Ready to Use Supplementary Food (RUSF) | Products, Kenya. The RUSF composition is in accordance with recommended supplementary feed composition specified by the latest WHO expert consultation in 2008 reported by Golden et al. It is formulated to provide 507 kcal per 100g, 6% protein/energy ratio and 55% fat/energy ratio. Essential fatty acids contained are N-6 (linoleic acid) 6 kcal % and N-3 (o-linoleic) 0.3 kcal %. Vitamin and mineral premix (3%) will provide the currently recommended nutrient intake for moderately malnourished children of minerals (K, Na, Ca, P, Mg, Fe, Zn, Cu, Se, I, Mn, Cr, Mo, F), Vitamins (thiamine, riboflavin, pyridoxine, niacin, Vit B12, folic acid, Vit C, Biotin, Pantothenic acid, Vit A, Vit D,Vit E and Vit K). initial visit. The amount supplied is based on the child's weight; the recommended energy supplement being 100kcal per kg per day which is equivalent to 25g RUSF per kg per day. |
| FG001 | 2 Normal Diet | For equity, parents or guardians of children in the usual diet arm are 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 RUSF | RUSF prescribed for the child for 4 weeks |
| BG001 | 2 Normal Diet | normal diet arm |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants recruited until trial was halted | Posted | Mean | 95% Confidence Interval | units on a scale | between enrolment and 4 weeks |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 RUSF | RUSF prescribed for the child for 4 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
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The trial was forced to stop early, 65 recruited. Analysis was inadequately powered to detect the changes in WHZ score and MUAC, the analysis of which had been originally planned for a sample size of 400.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr James Berkley | KEMRI/Wellcome Trust Research Programme | +254 41 522535 | jberkley@kilifi.kemri-wellcome.org |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D007239 | Infections |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Open label randomised trial of nutrition products
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| at 4 weeks and 3 months |
| Anemia (Hb <9.3g/dl) | at 4 weeks |
| Hospital Admission or Death | from enrolment to 3 months |
| Kilifi |
| Coast |
| 80108 |
| Kenya |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Description |
|---|
| OG000 | 1 RUSF | RUSF prescribed for the child for 4 weeks |
| OG001 | 2 Normal Diet | normal diet arm |
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| Secondary | WHZ Score at 3 Months | All participants recruited until trial halted | Posted | Mean | 95% Confidence Interval | Z scores | between enrolment and 3 months |
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| Secondary | MUAC for Age Z Score at 3 Months | All participants recruited until trial halted | Posted | Mean | 95% Confidence Interval | Z score | between enrolment and 4 weeks and at 3 months |
|
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| Secondary | Development of Severe Malnutrition (WHZ Score <-3 and/or Kwashiorkor) | All participants recruited until trial halted | Posted | Number | participants | at 4 weeks and 3 months |
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| Secondary | Anemia (Hb <9.3g/dl) | All participants recruited until trial halted | Posted | Number | participants | at 4 weeks |
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| Secondary | Hospital Admission or Death | All participants recruited until trial halted | Posted | Number | participants | from enrolment to 3 months |
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|
|
| 4 |
| 31 |
| 0 |
| 31 |
| EG001 | 2 Normal Diet | normal diet arm | 5 | 32 | 0 | 32 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Severe malnutrition | Metabolism and nutrition disorders | Systematic Assessment |
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