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Optimized Complementary Feeding With or Without Home Fortification Prevents Decrease of Micronutrient and Growth

U

Udayana University

Status

Completed

Conditions

Nutritional Status
Complementary Feeding
Growth Failure
Micronutrient Deficiency
Linear Programming

Treatments

Behavioral: Nutritional education program
Dietary Supplement: Home fortification (Taburia)

Study type

Interventional

Funder types

Other

Identifiers

NCT03891589
UdayanaU_01

Details and patient eligibility

About

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.

Full 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).

Enrollment

215 patients

Sex

All

Ages

6 to 11 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

215 participants in 4 patient groups

Optimized CF with Taburia
Experimental group
Description:
The intervention groups consisted of promotion of optimized complementary feeding with home fortification (taburia) one sachet per week
Treatment:
Dietary Supplement: Home fortification (Taburia)
Behavioral: Nutritional education program
Optimized CF only
Experimental group
Description:
The intervention groups consisted of promotion of optimized complementary feeding without home fortification (taburia)
Treatment:
Behavioral: Nutritional education program
Taburia
Experimental group
Description:
The intervention groups consisted of provision taburia home fortification three sachet per week
Treatment:
Dietary Supplement: Home fortification (Taburia)
Control
No Intervention group
Description:
No intervention but gave a standard education from primary health center

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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