The Impact of Nutrition Education & Milk Provision in NCT05489094

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number	NCT05489094
Other study ID #	270422
Secondary ID
Status	Not yet recruiting
Phase	Phase 4
First received
Last updated
Start date	August 31, 2022
Est. completion date	February 28, 2023

Study information
Verified date	August 2022
Source	Danone Specialized Nutrition Indonesia
Contact	Dr. dr. Dian N Chandra, M.Gizi
Phone	+62 815-9113-542
Email	diannovitach[@]yahoo.com
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status	Not yet recruiting
Enrollment	196
Est. completion date	February 28, 2023
Est. primary completion date	February 28, 2023
Accepts healthy volunteers	No
Gender	All
Age group	12 Months to 32 Months
Eligibility	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

Study Design

Related Conditions & MeSH terms

Intervention

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

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

Locations
Country	Name	City	State
n/a

Sponsors *(2)*
Lead Sponsor	Collaborator
Danone Specialized Nutrition Indonesia	Indonesian Nutrition Association

See also
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Withdrawn	`NCT03873584` - Improvement of Fatigue Symptoms in the Iron Deficiency Anemia With Iron Succinylate Therapy
Enrolling by invitation	`NCT03897673` - Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas	N/A
Completed	`NCT04359368` - Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions
Active, not recruiting	`NCT04778072` - A Clinical Study on Adherence and Efficacy of Different Doses of Active Iron in Treatment Resistant Subjects	N/A
Enrolling by invitation	`NCT05750940` - Oxidative Skeletal Muscle Metabolism in Chronic Heart Failure Patients With and Without Iron Deficiency
Recruiting	`NCT05126901` - Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, With a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years	Phase 3

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (2)

Outcome

Type	Measure	Description	Time frame
Primary	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	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	baseline
Secondary	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	1 month after baseline (visit1)
Secondary	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	2 months after baseline (visit2)
Secondary	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	3 months after baseline (visit3)
Secondary	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	4 months after baseline (visit4)
Secondary	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	baseline
Secondary	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	baseline
Secondary	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	baseline
Secondary	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	baseline
Secondary	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	1 month after baseline (visit1)
Secondary	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	1 month after baseline (visit1)
Secondary	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	1 month after baseline (visit1)
Secondary	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	1 month after baseline (visit1)
Secondary	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	2 months after baseline (visit2)
Secondary	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	2 months after baseline (visit2)
Secondary	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	2 months after baseline (visit2)
Secondary	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	2 months after baseline (visit2)
Secondary	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	3 months after baseline (visit3)
Secondary	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	3 months after baseline (visit3)
Secondary	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	3 months after baseline (visit3)
Secondary	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	3 months after baseline (visit3)
Secondary	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	4 months after baseline (visit4)
Secondary	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	4 months after baseline (visit4)
Secondary	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	4 months after baseline (visit4)
Secondary	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	4 months after baseline (visit4)
Secondary	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	baseline
Secondary	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	4 months after baseline (visit4)
Secondary	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	baseline
Secondary	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	1 month after baseline (visit1)
Secondary	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	2 months after baseline (visit1)
Secondary	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	3 months after baseline (visit1)
Secondary	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	4 months after baseline (visit1)