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

Primary Purpose

Complementary Feeding, Linear Programming, Nutritional Status

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Nutritional education program
Home fortification (Taburia)
Sponsored by
Udayana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Complementary Feeding focused on measuring Complementary feeding, Linear Programming, Nutritional status, Micronutrient, Growth

Eligibility Criteria

6 Months - 11 Months (Child)All SexesAccepts 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

Sites / Locations

  • Susut District

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Optimized CF with Taburia

Optimized CF only

Taburia

Control

Arm Description

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

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

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

No intervention but gave a standard education from primary health center

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Hemoglobin level
Hemoglobin level was carried out to determine the anemia status in children under five with the Flowcytometry method expressed in g/dL.
Change from baseline infection status (hs-CRP level) at 6 month
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.
Gut microbiota
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.
Helminth status
The helminthiasis was carried out using the Kato-Katz method
Dietary diversity
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.
Adherence to home fortification (taburia)
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.

Full Information

First Posted
March 14, 2019
Last Updated
March 24, 2019
Sponsor
Udayana University
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1. Study Identification

Unique Protocol Identification Number
NCT03891589
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Udayana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complementary Feeding, Linear Programming, Nutritional Status, Micronutrient Deficiency, Growth Failure
Keywords
Complementary feeding, Linear Programming, Nutritional status, Micronutrient, Growth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optimized CF with Taburia
Arm Type
Experimental
Arm Description
The intervention groups consisted of promotion of optimized complementary feeding with home fortification (taburia) one sachet per week
Arm Title
Optimized CF only
Arm Type
Experimental
Arm Description
The intervention groups consisted of promotion of optimized complementary feeding without home fortification (taburia)
Arm Title
Taburia
Arm Type
Experimental
Arm Description
The intervention groups consisted of provision taburia home fortification three sachet per week
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention but gave a standard education from primary health center
Intervention Type
Behavioral
Intervention Name(s)
Nutritional education program
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Home fortification (Taburia)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline nutrient intake at 6 months
Description
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.
Time Frame
Before intervention and after six month periode intervention
Title
Change from baseline nutrient density at 6 months
Description
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.
Time Frame
Before intervention and after six month periode intervention
Title
Change from baseline level of serum ferritin at 6 months
Description
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.
Time Frame
Before intervention and after six month period intervention
Title
Change from baseline Level of zinc serum at 6 months
Description
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.
Time Frame
Before intervention and after six month period intervention
Title
Change from baseline z-score anthropometry indices at 6 months
Description
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.
Time Frame
Carried out routinely every month for six months, starting at the beginning before and at the end of the intervention.
Secondary Outcome Measure Information:
Title
Hemoglobin level
Description
Hemoglobin level was carried out to determine the anemia status in children under five with the Flowcytometry method expressed in g/dL.
Time Frame
Measured at the end or after six month period of intervention
Title
Change from baseline infection status (hs-CRP level) at 6 month
Description
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.
Time Frame
Before intervention and after six month period intervention
Title
Gut microbiota
Description
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.
Time Frame
Measured at the end or after six month period of intervention
Title
Helminth status
Description
The helminthiasis was carried out using the Kato-Katz method
Time Frame
Measured at the end or after six month period of intervention
Title
Dietary diversity
Description
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.
Time Frame
After six month period of intervention
Title
Adherence to home fortification (taburia)
Description
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.
Time Frame
Carried out routinely every month for six months until the end of the intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
11 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kadek T Adhi
Organizational Affiliation
Udayana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Susut District
City
Bangli
State/Province
Bali
ZIP/Postal Code
80614
Country
Indonesia

12. IPD Sharing Statement

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

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