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

March 24, 2019 updated by: Kadek Tresna Adhi, Udayana University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
215

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Bali
      • Bangli, Bali, Indonesia, 80614
        • Susut District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 11 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Optimized CF with Taburia
The intervention groups consisted of promotion of optimized complementary feeding with home fortification (taburia) one sachet per week
Behavioral: Nutritional education program
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.
Dietary supplement: Home fortification (Taburia)
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.
Experimental: Optimized CF only
The intervention groups consisted of promotion of optimized complementary feeding without home fortification (taburia)
Behavioral: Nutritional education program
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.
Experimental: Taburia
The intervention groups consisted of provision taburia home fortification three sachet per week
Dietary supplement: Home fortification (Taburia)
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.
No Intervention: Control
No intervention but gave a standard education from primary health center

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline nutrient intake at 6 months
Time Frame: Before intervention and after six month periode intervention
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
Time Frame: Before intervention and after six month periode intervention
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
Time Frame: Before intervention and after six month period intervention
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
Time Frame: Before intervention and after six month period intervention
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
Time Frame: Carried out routinely every month for six months, starting at the beginning before and at the end of the intervention.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hemoglobin level
Time Frame: Measured at the end or after six month period of intervention
Hemoglobin level was carried out to determine the anemia status in children under five with the Flowcytometry method expressed in g/dL.
Measured at the end or after six month period of intervention
Change from baseline infection status (hs-CRP level) at 6 month
Time Frame: Before intervention and after six month period intervention
The hs-CRP level is an examination to measure the concentration of C-reactive protein which is more sensitive, measured by the enzyme-linked immunosorbent assay (ELISA) kit (Bioassay Technology Laboratory) Cat. No. E1805Hu and expressed in mg/L units.
Before intervention and after six month period intervention
Gut microbiota
Time Frame: Measured at the end or after six month period of intervention
The relative proportion of digestive tract bacterial DNA is the relative proportion of the DNA population of Bifidobacterium and Lactobacillus spp bacteria compared to the controls analysed using the qPCR method.
Measured at the end or after six month period of intervention
Helminth status
Time Frame: Measured at the end or after six month period of intervention
The helminthiasis was carried out using the Kato-Katz method
Measured at the end or after six month period of intervention
Dietary diversity
Time Frame: After six month period of intervention
The food diversity score is calculated by summing the number of food groups consumed by individual respondents during the 24-hour recall period. Scoring is done by giving a score of one if consuming and a score of 0 if not consuming one type of food contained in a food group that has been determined by FAO.
After six month period of intervention
Adherence to home fortification (taburia)
Time Frame: Carried out routinely every month for six months until the end of the intervention.
Adherence with the provision of taburia is the adherence of the mother or caregiver in giving taburia to the subject during the intervention program and is monitored directly by the researcher and field worker by collecting the number of sachets spent each month. The provision of taburia is given once a month as many as four sachets for group optimized CF with taburia and 12 sachets for group taburia only.
Carried out routinely every month for six months until the end of the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Udayana University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kadek T Adhi, Udayana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UdayanaU_01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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