Clinical trial NCT03891589: Optimized Complementary Feeding With or Without Home Fortification Prevents Decrease of Micronutrient and Growth
Official title: Promotion of Optimized Complementary Feeding With or Without Home Fortification (Taburia) Prevents the Decrease of Nutrient Intake, Level of Micronutrient, and Anthropometric Indices, Also Digestive Health Among Under-Five Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complementary Feeding
Linear Programming
Nutritional Status
Micronutrient Deficiency
Growth Failure
Keywords: Complementary feeding
Linear Programming
Nutritional status
Micronutrient
Growth
Lead sponsor: Udayana University
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 215
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The intervention groups consisted of promotion of optimized complementary feeding (CF) with taburia (P1, n=51), optimized CF (P2, n=54) and taburia home fortification (P3, n=47). Control groups will not receive intervention or placebo but will receive only a standardized primary health care education program related to complementary feeding practices for infants and children. Also, the nutritional status of all groups will be measured every month.
Primary purpose: PREVENTION

Brief summary: Malnourished among under-five children characterized by growth faltering is a public health concern in Indonesia. It requires serious action from the governments because of the prevalence of underweight, stunting, and wasting are increasing. These impacts are irreversible resulting in the low quality of future human resources. Several studies showed that growth faltering among under-five children starts at age six months when the amount of breastmilk reduced, complementary feeding initiated, and risk for infection is increased. A rapid growth phase also causes growth faltering at age 6-24 months. The inadequate amount and low quality of food during this period can also lead to reducing nutritional status. The Indonesian Government released a national policy in 2013 to address undernutrition among under-five children called the Indonesia President Regulation No. 42/2013 regarding national movements on the acceleration of nutritional programs to address micronutrients deficiency among under-five children by providing micronutrient powder (MNP) (called Taburia) for children aged 6 - 59 months. Our literature review documented that there is no study ever conducted to evaluate the effectiveness of MNP (Taburia) in improving the weight and height of the children. Moreover, behavioral modification interventions to promote food diversification to improve nutrient intake and to prevent micronutrient deficiency are also never conducted. Based on the rationale and study concept, the following hypotheses are 1). Promotion of optimized complementary feeding along with or without multi-micronutrient powder or MNP (namely taburia) can prevent reductions in nutrient intake and density; serum ferritin and zinc levels; and anthropometric z-score index compared to controls, and 2) provision of MNP can prevent reductions in nutrient intake and density; serum ferritin and zinc levels; and anthropometric z-score index compared to controls.

Detailed description: Our study consists of two phases. The first phase was to develop a combination model of Complementary Feeding Recommendation (CFR) or optimized Complementary Feeding (CF) with or without MNP home fortification (Taburia) by using a Linear Programming approach. The objective of this stage was to address the nutrient gaps. Also, nutrient analysis of Taburia by employing an LP approach will provide adequate dosing of Taburia to added to local CF. Several studies have documented that MNP supplementation associated with a reduced bacterial population in digestive systems (Lactobacillus dan Bifidobacterium spp) and induced inflammation on the intestines. These conditions reduce the absorption capacity of digestive systems leading to nutrient deficiency among under-five children. Findings from the first phase were an optimized model of CF with or without MNP (Taburia) as an intervention media in the second phase of our study, which evaluates the effectiveness of a combination of CFRs and MNP fortification using an LP approach. This intervention group compared to (1) optimal Complementary Feeding (CF) with MNP one sachet per week, (2) optimized CF group alone, (3) Provision MNP alone three sachets per week, and (4) control group. Several indicators to be evaluated were (1) nutrient intake and density; (2) z-score of anthropometric index; (3) micronutrient status; (4) digestive health status (relative population of DNA Bifidobacterium and Lactobacillus spp).

Eligibility criteria: Inclusion Criteria:

* Under-five children aged 6-11 months (baseline) with normal nutritional status based on weight for height/length z-score (more than -2 SD based on the World Health Organization (WHO) Growth standard (2006))
* Resided in the study location
* Parent or carer agreed to participate in the study and have signed informed consent.

Exclusion Criteria:

* Children with poor nutritional status (\<-2SD based on WHZ)
* Families refusing to participate

Primary outcomes:
measure: Change from baseline nutrient intake at 6 months
timeFrame: Before intervention and after six month periode intervention
measure: Change from baseline nutrient density at 6 months
timeFrame: Before intervention and after six month periode intervention
measure: Change from baseline level of serum ferritin at 6 months
timeFrame: Before intervention and after six month period intervention
measure: Change from baseline Level of zinc serum at 6 months
timeFrame: Before intervention and after six month period intervention
measure: Change from baseline z-score anthropometry indices at 6 months
timeFrame: Carried out routinely every month for six months, starting at the beginning before and at the end of the intervention.
Secondary outcomes:
measure: Hemoglobin level
timeFrame: Measured at the end or after six month period of intervention
measure: Change from baseline infection status (hs-CRP level) at 6 month
timeFrame: Before intervention and after six month period intervention
measure: Gut microbiota
timeFrame: Measured at the end or after six month period of intervention
measure: Helminth status
timeFrame: Measured at the end or after six month period of intervention
measure: Dietary diversity
timeFrame: After six month period of intervention
measure: Adherence to home fortification (taburia)
timeFrame: Carried out routinely every month for six months until the end of the intervention.
Other outcomes:
Locations:
city: Bangli
country: Indonesia
facility: Susut District
state: Bali
Study officials:
affiliation: Udayana University
name: Kadek T Adhi
role: PRINCIPAL_INVESTIGATOR
References: