A Phase 4 interventional study of Nutrition Education and Growing Up Milk for 1 - 3 years old and Nutrition Education in Iron-deficiency, sponsored by Danone Specialized Nutrition Indonesia. Status unknown. Open to participants aged 12 Months to 32 Months. Per ClinicalTrials.gov, last updated 2022-08-15.
Sponsored by Danone Specialized Nutrition Indonesia · Phase 4, Interventional, and Treatment
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.
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.
772 studies on the registry are indexed under Iron Deficiencies; 115 are open to participants now.
This study's planned enrollment of 196 is above the median of 100 across 592 interventional studies indexed under Iron Deficiencies.
Browse Iron Deficiencies studies →Danone Specialized Nutrition Indonesia is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
First group will be given nutrition education and iron intake from growing up milk approximately 2 - 3 servings/day for four months intervention period
Combination Product: Nutrition Education and Growing Up Milk for 1 - 3 years old
Second group will be given nutrition education only for four months intervention period
Behavioral: Nutrition Education
Nutrition education is a basic information related balanced nutrition for 1 - 3 children including the details of food types and calories. while Intervention product is formulated to deliver macro- and micronutrients as part of the dietary intake for children at 1-3 years old with Iron-C formula
Nutrition education is a basic information related balanced nutrition for 1 - 3 children including the details of food types and calories.
Impact of milk provision on change from baseline of daily iron intake at 4 month in intervention group vs control group
To know the impact of milk provision on change of daily iron intake using 24h recall and semi quantitative food frequency questionnaire in intervention group vs control group
Time frame: at baseline and at 4 months after baseline (visit4)
Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance
To know the adequacy of iron intake based on percentage of recommended daily allowance at baseline in intervention group vs control group
Time frame: baseline
Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance
To know the adequacy of iron intake based on percentage of recommended daily allowance at 1 month in intervention group vs control group
Time frame: 1 month after baseline (visit1)
Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance
To know the adequacy of iron intake based on percentage of recommended daily allowance at 2 months in intervention group vs control group
Time frame: 2 months after baseline (visit2)
Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance
To know the adequacy of iron intake based on percentage of recommended daily allowance at 3 months in intervention group vs control group
Time frame: 3 months after baseline (visit3)
Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance
To know the adequacy of iron intake based on percentage of recommended daily allowance at 4 months in intervention group vs control group
Time frame: 4 months after baseline (visit4)
Impact of milk provision on the average daily nutrients intake (Energy in kcal)
To know the average daily nutrients intake (Energy in kcal) at baseline in intervention group vs control group
Time frame: baseline
Impact of milk provision on the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g)
To know the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber \& DHA in g) at baseline in intervention group vs control group
Time frame: baseline
Impact of milk provision on the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg)
To know the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 \& Vit E in mg) at baseline in intervention group vs control group
Time frame: baseline
Impact of milk provision on the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D & Vit B12 in μg)
To know the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D \& Vit B12 in μg) at baseline in intervention group vs control group
Time frame: baseline
Impact of milk provision on the average daily nutrients intake (Energy in kcal)
To know the average daily nutrients intake (Energy in kcal) at 1 month in intervention group vs control group
Time frame: 1 month after baseline (visit1)
Impact of milk provision on the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g)
To know the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber \& DHA in g) at 1 month in intervention group vs control group
Time frame: 1 month after baseline (visit1)
Impact of milk provision on the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg)
To know the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 \& Vit E in mg) at 1 month in intervention group vs control group
Time frame: 1 month after baseline (visit1)
Impact of milk provision on the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D & Vit B12 in μg)
To know the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D \& Vit B12 in μg) at 1 month in intervention group vs control group
Time frame: 1 month after baseline (visit1)
Impact of milk provision on the average daily nutrients intake (Energy in kcal)
To know the average daily nutrients intake (Energy in kcal) at 2 months in intervention group vs control group
Time frame: 2 months after baseline (visit2)
Impact of milk provision on the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g)
To know the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber \& DHA in g) at 2 months in intervention group vs control group
Time frame: 2 months after baseline (visit2)
Impact of milk provision on the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg)
To know the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 \& Vit E in mg) at 2 months in intervention group vs control group
Time frame: 2 months after baseline (visit2)
Impact of milk provision on the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D & Vit B12 in μg)
To know the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D \& Vit B12 in μg) at 2 months in intervention group vs control group
Time frame: 2 months after baseline (visit2)
Impact of milk provision on the average daily nutrients intake (Energy in kcal)
To know the average daily nutrients intake (Energy in kcal) at 3 months in intervention group vs control group
Time frame: 3 months after baseline (visit3)
Impact of milk provision on the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g)
To know the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber \& DHA in g) at 3 months in intervention group vs control group
Time frame: 3 months after baseline (visit3)
Impact of milk provision on the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg)
To know the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 \& Vit E in mg) at 3 months in intervention group vs control group
Time frame: 3 months after baseline (visit3)
Impact of milk provision on the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D & Vit B12 in μg)
To know the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D \& Vit B12 in μg) at 3 months in intervention group vs control group
Time frame: 3 months after baseline (visit3)
Impact of milk provision on the average daily nutrients intake (Energy in kcal)
To know the average daily nutrients intake (Energy in kcal) at 4 months in intervention group vs control group
Time frame: 4 months after baseline (visit4)
Impact of milk provision on the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g)
To know the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber \& DHA in g) at 4 months in intervention group vs control group
Time frame: 4 months after baseline (visit4)
Impact of milk provision on the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg)
To know the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 \& Vit E in mg) at 4 months in intervention group vs control group
Time frame: 4 months after baseline (visit4)
Impact of milk provision on the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D & Vit B12 in μg)
To know the average daily nutrients intake (Folic Acid, Vit A, Vit C, Vit D \& Vit B12 in μg) at 4 months in intervention group vs control group
Time frame: 4 months after baseline (visit4)
Impact of milk provision on Total hemoglobin Level (SpHb) level using Masimo device
To know the hemoglobin level at baseline in intervention group vs control group
Time frame: baseline
Impact of milk provision on Total hemoglobin Level (SpHb) level using Masimo device
To know the hemoglobin level at 4 months in intervention group vs control group
Time frame: 4 months after baseline (visit4)
Impact of milk provision on nutritional status (weight, height - WAZ, HAZ, and WHZ)
To know the nutritional status (weight, height - WAZ, HAZ, and WHZ) at baseline in intervention group vs control group
Time frame: baseline
Impact of milk provision on nutritional status (weight, height - WAZ, HAZ, and WHZ)
To know the nutritional status (weight, height - WAZ, HAZ, and WHZ) at 1 month in intervention group vs control group
Time frame: 1 month after baseline (visit1)
Impact of milk provision on nutritional status (weight, height - WAZ, HAZ, and WHZ)
To know the nutritional status (weight, height - WAZ, HAZ, and WHZ) at 2 months in intervention group vs control group
Time frame: 2 months after baseline (visit1)
Impact of milk provision on nutritional status (weight, height - WAZ, HAZ, and WHZ)
To know the nutritional status (weight, height - WAZ, HAZ, and WHZ) at 3 months in intervention group vs control group
Time frame: 3 months after baseline (visit1)
Impact of milk provision on nutritional status (weight, height - WAZ, HAZ, and WHZ)
To know the nutritional status (weight, height - WAZ, HAZ, and WHZ) at 4 months in intervention group vs control group
Time frame: 4 months after baseline (visit1)
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Danone Specialized Nutrition Indonesia