Nutritional StatusNCT04413604
Micronutrient Status in Children Aged 1-3 Years Consuming Their Habitual Diet With or Without Young Children's Milk
A study testing Young children's milk (1-<3) in people with Nutritional Status and Child Nutrition Sciences, run by Société des Produits Nestlé (SPN) at 1 site in Indonesia.
Trial summary
This study evaluates changes in Vitamin D, Zinc, and Iron status of children consuming 2 servings / day of the investigational (test) young children's milk (YCM) for 16 weeks compared to children of the same age who consume their habitual pattern of beverage intake for the same duration. Read more about this study
- Who is it for?
- Ages 12 to 32 monthsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Status, Child Nutrition Sciences
- What is being tested?
- Young children's milk (1-<3)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteIndonesia
- Study dates
- 22 Oct 2021to 20 Jul 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Written informed consent has been obtained from the parent.
- Full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
- Child is age 12 - 32 months at enrolment.
- Child is no longer being breastfed (neither exclusively nor partially)
- Child's parent is of legal age of consent, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol.
Who cannot join
- Child has consumed micronutrient supplements or micronutrient fortified foods or beverages in amounts greater than the thresholds below:
- Micronutrient supplements (except for vitamin A): zero in the past 4 weeks
- Micronutrient-fortified foods or beverages: zero servings in the past 2 weeks
- Chronic infectious illness, helminthiasis, or other acute disease/disorder potentially affecting feeding or growth (mild infectious illness, such as acute viral rhinopharyngitis, is acceptable).
- Any congenital malformation (e.g., gastrointestinal tract atresia) or surgery sequelae (e.g. short bowel syndrome) potentially affecting feeding, growth, or nutrient absorption.
- Child exhibits any clinical signs of potential micronutrient deficiencies (e.g., hemoglobin < 100 g/L based on screening assessment, rickets based on physical exam).
Show all 13Show fewer
- Known or suspected cows' milk protein intolerance / allergy, lactose intolerance, soy intolerance / allergy, fish oil intolerance / allergy, or other food allergies that affect diet.
- Child fed vegan, vegetarian, or vegetarian plus fish diets in which milk products are excluded.
- Weight-for-age value < -2 or > 2 standard deviations from the WHO(world health organization) Child Growth Standards median at enrollment.
- Height-for-age < -2 or > 2 standard deviations from the WHO(world health organization) Child Growth Standards median at enrollment.
- Child has participated in another clinical trial within 4 weeks prior to enrollment.
- Child of any investigational site staff member or Nestle employee directly involved in the conduct of the trial.
- Other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Indonesian Nutrition Association
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
This study evaluates changes in Vitamin D, Zinc, and Iron status of children consuming 2 servings / day of the investigational (test) young children's milk (YCM) for 16 weeks compared to children of the same age who consume their habitual pattern of beverage intake for the same duration.
Read the detailed description
The overall purpose of the study is to demonstrate improved vitamin D status and/or improved iron status of children ages 1 to 3 years who are consuming the investigational (test) young children's milk (YCM) compared to children consuming their habitual pattern of beverage intake (milk and non-milk beverages). This is based on previous study findings that (i) the toddler's diet, in reality, is often not optimal, putting toddlers at risk of insufficient intakes of several nutrients, and (ii) consuming YCM supplemented with these nutrients might provide optimal intakes of these nutrients.
- Conditions
- Nutritional Status, Child Nutrition Sciences
- Being tested
- Young children's milk (1-<3)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Young children's milk (1-<3)Other
Also called YCM
young children's milk containing protein, energy and fat and micronutrients, in accordance with global and local nutritional recommendations for ages 1-3.
| Study group | Role | What they receive |
|---|---|---|
| YCM Group (1- <3) Years old | Experimental | 2 servings / day of the investigational (test) young children's milk (YCM) for 16 weeks Receives: Other: Young children's milk (1-<3) |
| Observation Group (1-<3) Years old | No intervention | Habitual diet, consume the same regular foods and drinks as the children would normally |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Vitamin D and Iron status
measure blood vitamin D and Iron value
Measured: 16 weeks
Secondary outcomes (2)
change in Zinc status
measure blood Zinc value
Measured: 16 weeks
Assess micronutrient intake
Using 24 hour dietary recall
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start22 Oct 2021
- Primary completion24 May 2022
- Study completion20 Jul 2022
Why it stopped: Due to recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional StatusStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sudigdo Sastroasmoro, MD, Principal investigator, Department of Child Health, Medical School, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413604
- Sponsor's protocol ID
- 19.08.INF
- Status last verified
- Jul 2022
- First submitted
- 27 Apr 2020
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micronutrient Status in Children Aged 1-3 Years Consuming Their Habitual Diet With or Without Young Children's Milk
- ClinicalTrials.gov ID
- NCT04413604
- Acronym / sponsor ID
- 19.08.INF
- Conditions
- Nutritional Status, Child Nutrition Sciences
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to recruitment difficulties
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 4 Jun 2020 (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.
This study evaluates changes in Vitamin D, Zinc, and Iron status of children consuming 2 servings / day of the investigational (test) young children's milk (YCM) for 16 weeks compared to children of the same age who consume their habitual pattern of beverage intake for the same duration.
Detailed description
The overall purpose of the study is to demonstrate improved vitamin D status and/or improved iron status of children ages 1 to 3 years who are consuming the investigational (test) young children's milk (YCM) compared to children consuming their habitual pattern of beverage intake (milk and non-milk beverages). This is based on previous study findings that (i) the toddler's diet, in reality, is often not optimal, putting toddlers at risk of insufficient intakes of several nutrients, and (ii) consuming YCM supplemented with these nutrients might provide optimal intakes of these nutrients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YCM Group (1- <3) Years old | Experimental | Other: Young children's milk (1-<3)2 servings / day of the investigational (test) young children's milk (YCM) for 16 weeks |
| Observation Group (1-<3) Years old | No intervention | –Habitual diet, consume the same regular foods and drinks as the children would normally |
Who may qualify
- Ages
- 12 to 32 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Written informed consent has been obtained from the parent.
- Full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
- Child is age 12 - 32 months at enrolment.
- Child is no longer being breastfed (neither exclusively nor partially)
- Child's parent is of legal age of consent, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol.
Key exclusion criteria (13 listed)
- Child has consumed micronutrient supplements or micronutrient fortified foods or beverages in amounts greater than the thresholds below:
- Chronic infectious illness, helminthiasis, or other acute disease/disorder potentially affecting feeding or growth (mild infectious illness, such as acute viral rhinopharyngitis, is acceptable).
- Any congenital malformation (e.g., gastrointestinal tract atresia) or surgery sequelae (e.g. short bowel syndrome) potentially affecting feeding, growth, or nutrient absorption.
- Child exhibits any clinical signs of potential micronutrient deficiencies (e.g., hemoglobin < 100 g/L based on screening assessment, rickets based on physical exam).
- Known or suspected cows' milk protein intolerance / allergy, lactose intolerance, soy intolerance / allergy, fish oil intolerance / allergy, or other food allergies that affect diet.
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 |
|---|---|---|
| Young children's milk (1-<3)Also: YCMyoung children's milk containing protein, energy and fat and micronutrients, in accordance with global and local nutritional recommendations for ages 1-3. | Other | YCM Group (1- <3) Years old |
Primary outcome
change in Vitamin D and Iron status
Time frame: 16 weeks
measure blood vitamin D and Iron value
2 secondary outcomes
change in Zinc status
Time frame: 16 weeks
Assess micronutrient intake
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: Due to recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
Related trials for Nutritional Status
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Recruiting
Confident Moves Intervention Efficacy Trial: Obesity Care Settings
Obesity, Overweight
Not yet recruiting
Stearic Acid and Endothelial Function
Healthy Middle-aged Subjects, Obesity & Overweight
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.
Sudigdo Sastroasmoro, MD principal investigator
Department of Child Health, Medical School, University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Young children's milk (1-<3) in people with Nutritional Status and Child Nutrition Sciences, run by Société des Produits Nestlé (SPN) at 1 site in 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 5 inclusion and 13 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: stopped early, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Vitamin D and Iron status (time frame: 16 weeks). 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 1 Aug 2022.