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The Impact of Nutrition Education and Milk Provision in Fueling the Progress of 1 - 3 Years Old Children

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Danone

Status and phase

Not yet enrolling
Phase 4

Conditions

Iron-deficiency

Treatments

Behavioral: Nutrition Education
Combination Product: Nutrition Education and Growing Up Milk for 1 - 3 years old

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

196 estimated patients

Sex

All

Ages

12 to 32 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

196 participants in 2 patient groups, including a placebo group

Intervention Group
Active Comparator group
Description:
First group will be given nutrition education and iron intake from growing up milk approximately 2 - 3 servings/day for four months intervention period
Treatment:
Combination Product: Nutrition Education and Growing Up Milk for 1 - 3 years old
Control Group
Placebo Comparator group
Description:
Second group will be given nutrition education only for four months intervention period
Treatment:
Behavioral: Nutrition Education

Trial contacts and locations

0

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Central trial contact

Dr. dr. Dian N Chandra, M.Gizi

Data sourced from clinicaltrials.gov

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