Malnutrition; Moderate Clinical Trial
Official title:
Effectiveness, Tolerability and Safety of Standardized Milk-based, Standardized Non-milk Based and Hospital-based Formulations in the Management of Moderate Acute Malnutrition in Underfive Children: A Randomized Clinical Trial
This is a randomized clinical trial aimed at evaluating the effectiveness, tolerability and safety of standardized milk-based formulation, standardized non-milk based formulation and a hospital-based formulation in the management of children aged 6 - 59 months with moderate acute malnutrition. Eligible children will be randomized into one of the three intervention arms and given supplementary doses of the formulations at 50% of their daily caloric requirement for a period of four months based on the group of their assignment. The remainder will be obtained from their regular family diets. The clinical features, anthropometric measurements and laboratory parameters of the children will be assessed at baseline. The children will be followed up on two weekly basis for a period of four months during which further clinical assessment, anthropometric measurements and laboratory evaluations will be performed. The outcome measures will be determined based on "per protocol analysis".
Childhood malnutrition is presently a leading cause of underfive morbidity and mortality
globally. The impact of the condition is most severe in the first 1000 days of life with
resultant impairment in physical, neurologic, immunologic and metabolic development.
Undernutrition, the commoner form of childhood malnutrition, is usually classified as
underweight (weight-for-age Z score < -2), stunting (height-for-age Z score <-2), wasting
(weight-for-height Z score < -2) or edematous malnutrition (kwashiorkor) in relation to the
World Health Organization standard reference values for age and sex. It is further
sub-classified into severe acute malnutrition (SAM) wherein z score is <-3 and moderate acute
malnutrition (MAM) wherein z score is between -2 and -3.(1) MAM accounts for about 70.0% of
all malnutrition-related childhood deaths.
Children with MAM are currently managed using community-based approach. This approach entails
early detection and treatment of children with MAM in the community, timely referral to
inpatient care for those that progress to SAM or develop complications, and subsequent follow
up in the community at discharge. MAM is usually managed by nutrition education of the
caregivers on preparation of nutritious, palatable and culturally acceptable food from
locally available food stuffs like banana porridge or corn gruel fortified with legume
(mashed groundnut or soya bean), crayfish, palm oil, powdered milk and vegetables. The second
strategy is by Ready-to-use therapeutic foods (RUTFs). (2) The main drawback of the RUTFs is
that they are usually provided by external donor agencies and as such, not always available
in settings where childhood malnutrition is endemic. Children treated with RUTFs are
therefore at risk of progressing to SAM or dying when the formulations are no longer
available. There is currently no consensus on the appropriate nutritional formulation for
community-based management of MAM in children in endemic regions. It is therefore imperative
to evaluate the effect of readily available formulations that are comparable to the RUTFs in
community-based management of childhood MAM in endemic regions. (3) The standardized
milk-based formulation (SMBF), the standardized non milk-based formulation (SNMBF) and the
hospital-based formulation (HBF) are examples of formulations that are readily available in
the country. The SMBF consists of maize and is rich in methionine, the SNMBF consists of
maize and soybeans, and is rich in methionine and lysine while the HBF consist of a
combination of maize, milk and soybeans. The nutrient composition of the above-mentioned
formulations is similar to that of the RUTFs, making them suitable for community-based
management of MAM. However, no clinical trial has so far been conducted to evaluate their
effect in managing underfive children with MAM. The cost effectiveness of the various
formulations will also be assessed.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04492644 -
The Correlation Among Nutrition, Muscle Strength, Masticatory and Swallow Ability of Inpatient Elders
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