Iron-deficiencyPhase 4NCT05489094
The Impact of Nutrition Education and Milk Provision in Fueling the Progress of 1 - 3 Years Old Children
A Phase 4 study testing Nutrition Education and Growing Up Milk for 1 - 3 years old and Nutrition Education in people with Iron-deficiency, run by Danone Specialized Nutrition Indonesia.
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… Read more about this study
- Who is it for?
- Ages 12 to 32 months
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- Nutrition Education and Growing Up Milk for 1 - 3 years old and Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2022to 28 Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 32 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed 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.
- Conditions
- Iron-deficiency
- Being tested
- Nutrition Education and Growing Up Milk for 1 - 3 years old, Nutrition Education
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition Education and Growing Up Milk for 1 - 3 years oldCombination 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
Nutrition EducationBehavioural
Nutrition education is a basic information related balanced nutrition for 1 - 3 children including the details of food types and calories.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
To know the adequacy of iron intake based on percentage of recommended daily allowance at baseline in intervention group vs control group
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 4 months after baseline (visit1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start31 Aug 2022 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized non blinded and controlled study
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danone Specialized Nutrition Indonesia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indonesian Nutrition Association
- Responsible party
- Sponsor
- Investigators
- Dr. dr. Dian N Chandra, M.Gizi, Principal investigator, Indonesian Nutrition Association (INA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489094
- Sponsor's protocol ID
- 270422
- Status last verified
- Aug 2022
- First submitted
- 26 Jul 2022
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Nutrition Education and Milk Provision in Fueling the Progress of 1 - 3 Years Old Children
- ClinicalTrials.gov ID
- NCT05489094
- Acronym / sponsor ID
- 270422
- Conditions
- Iron-deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Danone Specialized Nutrition IndonesiaIndustry (pharma, biotech, devices)
- Collaborators
- Indonesian Nutrition Association
- Study start
- 31 Aug 2022 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized non blinded and controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Combination Product: Nutrition Education and Growing Up Milk for 1 - 3 years oldFirst group will be given nutrition education and iron intake from growing up milk approximately 2 - 3 servings/day for four months intervention period |
| Control Group | Placebo comparator | Behavioral: Nutrition EducationSecond group will be given nutrition education only for four months intervention period |
Who may qualify
- Ages
- 12 to 32 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition Education and Growing Up Milk for 1 - 3 years oldNutrition 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 | Combination product | Intervention Group |
| Nutrition EducationNutrition education is a basic information related balanced nutrition for 1 - 3 children including the details of food types and calories. | Behavioural | Control Group |
Primary outcome
Impact of milk provision on change from baseline of daily iron intake at 4 month in intervention group vs control group
Time frame: at baseline and at 4 months after baseline (visit4)
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
32 secondary outcomes
Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance
Time frame: baseline
Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance
Time frame: 1 month after baseline (visit1)
Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance
Time frame: 2 months after baseline (visit2)
Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance
Time frame: 3 months after baseline (visit3)
Impact of milk provision on the adequacy of iron intake based on percentage of recommended daily allowance
Time frame: 4 months after baseline (visit4)
Impact of milk provision on the average daily nutrients intake (Energy in kcal)
Time frame: baseline
Impact of milk provision on the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g)
Time frame: baseline
Impact of milk provision on the average daily nutrients intake (Fe, Ca, P, Zn, Mg, Vit B6 & Vit E in mg)
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)
Time frame: baseline
Impact of milk provision on the average daily nutrients intake (Energy in kcal)
Time frame: 1 month after baseline (visit1)
Impact of milk provision on the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g)
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)
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)
Time frame: 1 month after baseline (visit1)
Impact of milk provision on the average daily nutrients intake (Energy in kcal)
Time frame: 2 months after baseline (visit2)
Impact of milk provision on the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g)
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)
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)
Time frame: 2 months after baseline (visit2)
Impact of milk provision on the average daily nutrients intake (Energy in kcal)
Time frame: 3 months after baseline (visit3)
Impact of milk provision on the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g)
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)
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)
Time frame: 3 months after baseline (visit3)
Impact of milk provision on the average daily nutrients intake (Energy in kcal)
Time frame: 4 months after baseline (visit4)
Impact of milk provision on the average daily nutrients intake (Protein, Carbohydrate, Fat, Fiber & DHA in g)
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)
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)
Time frame: 4 months after baseline (visit4)
Impact of milk provision on Total hemoglobin Level (SpHb) level using Masimo device
Time frame: baseline
Impact of milk provision on Total hemoglobin Level (SpHb) level using Masimo device
Time frame: 4 months after baseline (visit4)
Impact of milk provision on nutritional status (weight, height - WAZ, HAZ, and WHZ)
Time frame: baseline
Impact of milk provision on nutritional status (weight, height - WAZ, HAZ, and WHZ)
Time frame: 1 month after baseline (visit1)
Impact of milk provision on nutritional status (weight, height - WAZ, HAZ, and WHZ)
Time frame: 2 months after baseline (visit1)
Impact of milk provision on nutritional status (weight, height - WAZ, HAZ, and WHZ)
Time frame: 3 months after baseline (visit1)
Impact of milk provision on nutritional status (weight, height - WAZ, HAZ, and WHZ)
Time frame: 4 months after baseline (visit1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. dr. Dian N Chandra, M.Gizi principal investigator
Indonesian Nutrition Association (INA)
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nutrition Education and Growing Up Milk for 1 - 3 years old and Nutrition Education in people with Iron-deficiency, run by Danone Specialized Nutrition Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. dr. Dian N Chandra, M.Gizi (+62 815-9113-542, diannovitach@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of milk provision on change from baseline of daily iron intake at 4 month in intervention group vs control group (time frame: at baseline and at 4 months after baseline (visit4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.