Status and phase
Conditions
Treatments
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
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
196 participants in 2 patient groups, including a placebo group
Loading...
Central trial contact
Dr. dr. Dian N Chandra, M.Gizi
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal