Clinical trial NCT05489094: The Impact of Nutrition Education and Milk Provision in Fueling the Progress of 1 - 3 Years Old Children
Official title: The Impact of Nutrition Education and Milk Provision in Fueling the Progress of 1 - 3 Years Old Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Iron-deficiency
Lead sponsor: Danone Specialized Nutrition Indonesia
Sponsor class: INDUSTRY
Collaborators: name: Indonesian Nutrition Association
First posted: 2022-08-05
Enrollment: 196
Sex: ALL
Minimum age (years): 12
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized non blinded and controlled study
Primary purpose: TREATMENT

Brief summary: The study will be conducted by the Indonesia Nutrition Association that led by a Principle Investigator and supported by the study team consisted of Nutritionists.

The aims of the study are to reduce iron deficiency by increasing iron intake in children 1-3 years by providing interventions in the form of increasing iron intake from growing up milk for four months and nutrition education for the intervention group and nutrition education only for the control group.

Detailed description: The study will be conducted by the Indonesia Nutrition Association that led by a Principle Investigator and supported by the study team consisted of Nutritionists.

The aim of the study is to reduce iron deficiency by increasing iron intake in children 1-3 years (min 40%) by providing interventions in the form of increasing iron intake from growing up milk and nutrition education for the intervention group and nutrition education only for the control group for four months intervention period.

The subject for the study is 2 x 98 children for a cluster randomization control trial study residing in Kampung Melayu, East Jakarta. After signed informed consent had been obtained from parents/caretakers, baseline characteristics (demographics, medical history, pre-existing conditions, weight, and height) were collected and recorded. Children that have passed the requirements to be included and not to be excluded based on inclusion and exclusion criteria will be collected and recorded their data based on the protocol.

All children in the intervention group will be receiving nutrition education and growing up milk approximately 2-3 servings/day during the intervention period, whereas those who are in the control group will receive only nutrition education. Their data will be collected and recorded for the study.

During the intervention period, in a regular period, children in the study, will be measured on parameters that are stated above. Screening, enrolment, baseline measurements, subsequent assessments at 1, 2, 3, and 4 months of intervention will be done at the community health center in Jakarta. The monitoring to ensure adherent to the intervention will be conducted via home visits by health workers.

Eligibility criteria: Inclusion Criteria:

* Apparently healthy Indonesian children
* Age 12 - 32 months at baseline visit
* Willing to take min 2 serving of study product per day
* Daily Iron intake less than 80% of Indonesian RDA (\<5.6 mg/day)
* Planning to reside in the study area during the next 4 months
* Written informed consent by parent(s) or legally acceptable representative (in ICF there is statement that both are agree that child participate in the study)

Exclusion Criteria:

* Having Hb \<8 g/dL using Hemocue
* Having cow's milk allergy, galactosemia, conditions needing a special diet, like major renal and hepatic dysfunction, major gastrointestinal intolerance (e.g., severe vomiting, severe diarrhea), investigator's uncertainty about the willingness or ability of the child/carer to comply with the protocol requirements, participation in any other study within two weeks prior to entry into the study

Primary outcomes:
measure: Impact of milk provision on change from baseline of daily iron intake at 4 month in intervention group vs control group
timeFrame: at baseline and at 4 months after baseline (visit4)
Secondary outcomes:
measure: Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance
timeFrame: baseline
measure: Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance
timeFrame: 1 month after baseline (visit1)
measure: Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance
timeFrame: 2 months after baseline (visit2)
measure: Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance
timeFrame: 3 months after baseline (visit3)
measure: Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance
timeFrame: 4 months after baseline (visit4)
measure: Impact of milk provision on the average daily nutrients intake (Energy in kcal)
timeFrame: baseline
measure: Impact of milk provision on the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g)
timeFrame: baseline
measure: Impact of milk provision on the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg)
timeFrame: baseline
measure: Impact of milk provision on the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D & Vit B12 in μg)
timeFrame: baseline
measure: Impact of milk provision on the average daily nutrients intake (Energy in kcal)
timeFrame: 1 month after baseline (visit1)
measure: Impact of milk provision on the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g)
timeFrame: 1 month after baseline (visit1)
measure: Impact of milk provision on the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg)
timeFrame: 1 month after baseline (visit1)
measure: Impact of milk provision on the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D & Vit B12 in μg)
timeFrame: 1 month after baseline (visit1)
measure: Impact of milk provision on the average daily nutrients intake (Energy in kcal)
timeFrame: 2 months after baseline (visit2)
measure: Impact of milk provision on the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g)
timeFrame: 2 months after baseline (visit2)
measure: Impact of milk provision on the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg)
timeFrame: 2 months after baseline (visit2)
measure: Impact of milk provision on the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D & Vit B12 in μg)
timeFrame: 2 months after baseline (visit2)
measure: Impact of milk provision on the average daily nutrients intake (Energy in kcal)
timeFrame: 3 months after baseline (visit3)
measure: Impact of milk provision on the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g)
timeFrame: 3 months after baseline (visit3)
measure: Impact of milk provision on the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg)
timeFrame: 3 months after baseline (visit3)
measure: Impact of milk provision on the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D & Vit B12 in μg)
timeFrame: 3 months after baseline (visit3)
measure: Impact of milk provision on the average daily nutrients intake (Energy in kcal)
timeFrame: 4 months after baseline (visit4)
measure: Impact of milk provision on the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g)
timeFrame: 4 months after baseline (visit4)
measure: Impact of milk provision on the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg)
timeFrame: 4 months after baseline (visit4)
measure: Impact of milk provision on the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D & Vit B12 in μg)
timeFrame: 4 months after baseline (visit4)
measure: Impact of milk provision on Total hemoglobin Level (SpHb) level using Masimo device
timeFrame: baseline
measure: Impact of milk provision on Total hemoglobin Level (SpHb) level using Masimo device
timeFrame: 4 months after baseline (visit4)
measure: Impact of milk provision on nutritional status (weight, height - WAZ, HAZ, and WHZ)
timeFrame: baseline
measure: Impact of milk provision on nutritional status (weight, height - WAZ, HAZ, and WHZ)
timeFrame: 1 month after baseline (visit1)
measure: Impact of milk provision on nutritional status (weight, height - WAZ, HAZ, and WHZ)
timeFrame: 2 months after baseline (visit1)
measure: Impact of milk provision on nutritional status (weight, height - WAZ, HAZ, and WHZ)
timeFrame: 3 months after baseline (visit1)
measure: Impact of milk provision on nutritional status (weight, height - WAZ, HAZ, and WHZ)
timeFrame: 4 months after baseline (visit1)
Other outcomes:
Locations:
Study officials:
affiliation: Indonesian Nutrition Association (INA)
name: Dr. dr. Dian N Chandra, M.Gizi
role: PRINCIPAL_INVESTIGATOR
References: