Trial Outcomes & Findings for Effectiveness of Supplementary Feeding During Infection Among Moderately Malnourished Children (NCT NCT00890695)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

64 participants

Primary outcome timeframe

between enrolment and 4 weeks

Results posted on

2017-08-14

Participant Flow

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.

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 Randomization was carried out on 65 children who were eligible and whose carers consented. 1 was withdrawn: weight for height Z score (WHZ) was found to be \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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	32	33
Overall Study COMPLETED	31	33
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Protocol Violation	1	0

Baseline Characteristics

Effectiveness of Supplementary Feeding During Infection Among Moderately Malnourished Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1 RUSF n=31 Participants RUSF prescribed for the child for 4 weeks	2 Normal Diet n=33 Participants normal diet arm	Total n=64 Participants Total of all reporting groups
Age, Categorical <=18 years	31 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	1.21 years STANDARD_DEVIATION 0.55 • n=5 Participants	1.15 years STANDARD_DEVIATION 0.46 • n=7 Participants	1.18 years STANDARD_DEVIATION 0.50 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment Kenya	31 participants n=5 Participants	33 participants n=7 Participants	64 participants n=5 Participants

PRIMARY outcome

Timeframe: between enrolment and 4 weeks

Population: All participants recruited until trial was halted

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.