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

NCT05489094 | Unknown Phase 4 DMC

• 1 other identifier: 270422
• Study Type: interventional
• Target: 196
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Iron-deficiency

Outcome Measures

Primary Outcomes (1)

• 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

  at baseline and at 4 months after baseline (visit4)

Secondary Outcomes (32)

• Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance

  baseline

• Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance

  1 month after baseline (visit1)

• Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance

  2 months after baseline (visit2)

• Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance

  3 months after baseline (visit3)

• Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance

  4 months after baseline (visit4)

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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

Control Group

PLACEBO COMPARATOR

Second group will be given nutrition education only for four months intervention period

Behavioral: Nutrition Education

Interventions

Nutrition Education and Growing Up Milk for 1 - 3 years old COMBINATION_PRODUCT

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

Intervention Group

Nutrition Education BEHAVIORAL

Nutrition education is a basic information related balanced nutrition for 1 - 3 children including the details of food types and calories.

Control Group

Eligibility Criteria

• Age: 12 Months - 32 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Danone Specialized Nutrition Indonesia: lead
• Indonesian Nutrition Association: collaborator

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Dr. dr. Dian N Chandra, M.Gizi

  Indonesian Nutrition Association (INA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. dr. Dian N Chandra, M.Gizi

CONTACT

+62 815-9113-542; diannovitach@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized non blinded and controlled study

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 5, 2022
• Study Start: August 31, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share