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Complementary FeedingNCT03891589

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

A study testing Nutritional education program and Home fortification (Taburia) in people with Complementary Feeding and Linear Programming, run by Udayana University at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 11 monthsHealthy volunteers can take part
What is being tested?
Nutritional education program and Home fortification (Taburia)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
215 participants
Where
1 siteIndonesia
Study dates
1 Jan 2018to 31 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 11 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site
  • Susut District

    Bangli, Bali, 80614

Other trials in Indonesia

About this study

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

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.

Read the 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).

Being tested
Nutritional education program, Home fortification (Taburia)
Keywords
Complementary feeding, Linear Programming, Nutritional status, Micronutrient, Growth
Medical subject headings
Failure to Thrive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional education programBehavioural

    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.

  • 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.

Study groups in NCT03891589
Study groupRoleWhat they receive
Optimized CF with TaburiaExperimentalThe intervention groups consisted of promotion of optimized complementary feeding with home fortification (taburia) one sachet per week
Receives: Behavioral: Nutritional education program; Dietary Supplement: Home fortification (Taburia)
Optimized CF onlyExperimentalThe intervention groups consisted of promotion of optimized complementary feeding without home fortification (taburia)
Receives: Behavioral: Nutritional education program
TaburiaExperimentalThe intervention groups consisted of provision taburia home fortification three sachet per week
Receives: Dietary Supplement: Home fortification (Taburia)
ControlNo interventionNo intervention but gave a standard education from primary health center

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Before intervention and after six month periode intervention

  2. 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.

    Measured: Before intervention and after six month periode intervention

  3. 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.

    Measured: Before intervention and after six month period intervention

  4. 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.

    Measured: Before intervention and after six month period intervention

  5. 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.

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

Secondary outcomes (6)
  1. Hemoglobin level

    Hemoglobin level was carried out to determine the anemia status in children under five with the Flowcytometry method expressed in g/dL.

    Measured: Measured at the end or after six month period of intervention

  2. 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.

    Measured: Before intervention and after six month period intervention

  3. 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.

    Measured: Measured at the end or after six month period of intervention

  4. Helminth status

    The helminthiasis was carried out using the Kato-Katz method

    Measured: Measured at the end or after six month period of intervention

  5. 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.

    Measured: After six month period of intervention

  6. 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.

    Measured: Carried out routinely every month for six months until the end of the intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2019
  2. Study start1 Jan 2018
  3. Primary completion1 Apr 2018
  4. Study completion31 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
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)
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03891589
Sponsor's protocol ID
UdayanaU_01
Status last verified
Mar 2019
First submitted
14 Mar 2019
Last updated
27 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional education program and Home fortification (Taburia) in people with Complementary Feeding and Linear Programming, run by Udayana University at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline nutrient intake at 6 months (time frame: Before intervention and after six month periode intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.

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