The Efficacy of Amino Acid Supplementation in Treating Environmental Enteric Dysfunction Among Children At Risk of Malnutrition

Обзор

A randomised controlled open label clinical trial to determine whether addition of indispensable amino acids (IAA) to standard complementary food will reduce occurrence of Environmental Enteric Dysfunction (EED) compared with provision of standard complementary food without IAA in healthy Malawian children aged 18-36 months with or without stunting.

Вмешательства

• Пищевая добавка Corn soy bean blended flour porridge plus indispensable amino acid
  Protocol treatment will start within two weeks of enrollment to the study. Following the baseline study assessments, each participant will receive corn-soy bean blended flour porridge supplemented with IAAs (histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, and valine) dosed at 12g/d and providing 1.5 times the estimated average requirement (EAR) for a healthy child (Intervention group). The porridge will provide 30% daily energy requirement. The study foo

Первичные конечные точки

• corn soy bean flour porridge with added indespensable amino acids [Срок оценки: 30 days]

Вторичные конечные точки (1)

• Corn soy bean flour porridge [Срок оценки: 30 days]

Критерии участия

Критерии включения

• All children identified from the Mangochi DSS whose guardian/parent desires screening will be eligible for screening. This will first include age, weight, length, and MUAC assessment. If a participant meets age and anthropometric criteria, they will be invited to undergo full inclusion/exclusion criteria assessment, consent, and randomization.

In order to be eligible to participate in the study, an individual must meet all of the following criteria:

• 18-36 months old (now agreed to by all countries)
• Stunted (LAZ\<-2)
• Of either sex
• Able and willing to undergo HIV testing
• Parent, carer, or guardian able and willing to give written, informed consent
• A positive HIV test result will not be an exclusion criterion.

Критерии исключения

• An individual who meets any of the following criteria will be excluded from participation in this study:

• Under 18 months of age
• Over 36 months old
• Wasted (weight-for-length Z-score less than -2)
• Overweight (weight-for-length Z-score greater than 2)
• Have had diarrhea (by self-report) in the preceding month
• Sibling or twin of another participating study child (2 children of different families in the same household are both eligible)
• Have any underlying condition other than HIV, which in the opinion of the investigator would put the subject at undue risk of failing study completion or would interfere with analysis of study results

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Malawi · 1 центр

• Kamuzu University of Health Sciences — Blantyre

Публикации

• Lee GO, Owino V, Baquiran AFP, Pasanna RM, Achoribo SE, Meskini T, Amadi B, Maleta KM, Gaudichon C, Serafico ME, Hegde S, Cabanilla CVD, Devi S, El Mzibri M, Brouwer AF, Kurpad AV, Kelly P, Morrison D. Impact of indispensable amino acid supplementation on gut function in children at high risk of environmental enteropathy: protocol for an international coordinated group of randomised controlled tri PMID 42031499

Идентификаторы

NCT: NCT06617130 · P.02/23/3992

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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