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

NCT03891589 | Completed

• 1 other identifier: UdayanaU_01
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

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.

Conditions

Complementary Feeding; Linear Programming; Nutritional Status; Micronutrient Deficiency; Growth Failure

Keywords

Complementary feeding; Linear Programming; Nutritional status; Micronutrient; Growth

Outcome Measures

Primary Outcomes (5)

• Change from baseline nutrient intake at 6 months

  Data related to nutrient intake nutrient before and after the intervention measured using a 24-hour recall and a food frequency questionnaire and collected through a structured interview. Also, data related to compliance, side effects, and acceptability of MNP home fortification (Taburia) evaluated directly by the research team during the intervention period. Nutrient composition in-home fortification (Taburia) also includes in analysis Nutrisurvey software.

  Before intervention and after six month periode intervention

• Change from baseline nutrient density at 6 months

  Data related to nutrient density before and after the intervention measured using a 24-hour recall and a food frequency questionnaire and collected through a structured interview. Nutrient density is calculated from intake ratio or total nutrient obtained from the diet divided by total energy from the diet per 100 kcal. Dietary data measured using a food scale (Tanita KD-160) as well as household measurements such as glass, plate, spoon, bowl, and others.

  Before intervention and after six month periode intervention

• Change from baseline level of serum ferritin at 6 months

  Serum ferritin level measured by the Enzyme-linked immunosorbent assay (ELISA) kit (Bioassay Technology Laboratory) Cat. No. E1702Hu and expressed in units of μg/ml.

  Before intervention and after six month period intervention

• Change from baseline Level of zinc serum at 6 months

  The serum zinc level measured using the GBC 933 AA type atomic absorption spectrophotometer (AAS) with a wavelength of 213.9 nm and expressed in units of μmol/L.

  Before intervention and after six month period intervention

• Change from baseline z-score anthropometry indices at 6 months

  Weight and height of the children measured before the intervention and will be followed by regular measurement every month until the end of the intervention period. These data analyzed using the WHO Anthro 2005 software to calculate z-score anthropometric index (weight for age, length for age, weight for height) and presented as z-score to determine the nutritional status of our samples. Body weight measured using a digital EBSC infant weigher with the accuracy of 0.01 kg and using a standing digital weigher (CAMRY) with an accuracy of 0.01 kg for children who already can stand up. Length or height measured using a length board (SECA 210) with an accuracy of 0.01 cm.

  Carried out routinely every month for six months, starting at the beginning before and at the end of the intervention.

Secondary Outcomes (6)

• Hemoglobin level

  Measured at the end or after six month period of intervention

• Change from baseline infection status (hs-CRP level) at 6 month

  Before intervention and after six month period intervention

• Gut microbiota

  Measured at the end or after six month period of intervention

• Helminth status

  Measured at the end or after six month period of intervention

• Dietary diversity

  After six month period of intervention

Study Arms (4)

Optimized CF with Taburia

EXPERIMENTAL

The intervention groups consisted of promotion of optimized complementary feeding with home fortification (taburia) one sachet per week

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

Optimized CF only

EXPERIMENTAL

The intervention groups consisted of promotion of optimized complementary feeding without home fortification (taburia)

Behavioral: Nutritional education program

Taburia

EXPERIMENTAL

The intervention groups consisted of provision taburia home fortification three sachet per week

Dietary Supplement: Home fortification (Taburia)

Control

NO INTERVENTION

No intervention but gave a standard education from primary health center

Interventions

Nutritional education program BEHAVIORAL

These programs were a process of providing information or knowledge to mother of the children consisting of information on initiation of complementary feeding, variety, and frequency of food, nutrient requirements and diet pattern for children (the amount and types of food), and benefits of Taburia. All this information provided through class-based activities and group discussion by using leaflet and food model conducted by the researchers. Education materials developed based on CFR models from our previous study by applying the LP approach. There was also a demonstration on administering complementary feeding (demo and cooking class) to improve skills of the mother on food from selection, design, handling and preparing, based on requirements of the children. This activity conducted through training once per month for the first four months of the intervention. Components of complementary feeding promoted in this study are based on CFR using LP approach from our previous research.

Optimized CF only; Optimized CF with Taburia

Home fortification (Taburia) DIETARY_SUPPLEMENT

Taburia is a multivitamin and mineral fortification to provide sufficient amount of nutrient for optimal growth and development of children aged 6-59 months. Every sachet of Taburia prepared to fulfill minimum nutrient requirements for children aged 6-59 months. Each sachet is one gram in weight and contains vitamin A (417 mcg), B1 (0.5 mg), B2 (0.5 mg), B3 (5.0 mg), B6 (0.5 mg), B12 (1 mcg), D3 (5 mcg), E (6 mg), K (20 mcg), C (30 mcg), folic acid (150 mcg), pantothenic acid (3 mcg), Iodium (50 mcg), Iron (10 mg), Zn (5 mg) and Selenium (20 mcg). One sachet of Taburia given to the subject by adding it to their breakfast and must be finished. The frequency of Taburia consumption per week follows the finding of the LP analysis from the previous study. Taburia intervention complemented by health education related to benefits, administration of Taburia, and its side effects. Compliance will be evaluated directly by the researcher based on empty Taburia sachet and conducted every month.

Optimized CF with Taburia; Taburia

Eligibility Criteria

• Age: 6 Months - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Udayana University: lead

Study Sites (1)

Susut District

Bangli, Bali, 80614, Indonesia

Location

MeSH Terms

Conditions

Failure to Thrive

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kadek T Adhi

  Udayana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 27, 2019
• Study Start: January 1, 2018
• Primary Completion: April 1, 2018
• Study Completion: October 31, 2018
• Last Updated: March 27, 2019

Record last verified: 2019-03

Locations

ID (1)