AnemiaNCT05181436
The Prevalence of Malaysian Children Aged ≥ 6 to ≤ 36 Months at Risk of Anaemia
An observational study of Anemia, run by Danone Specialized Nutrition (M) Sdn Bhd at 1 site in Malaysia.
Trial summary
The main purpose of this study is to determine the prevalence of Malaysian children aged ≥ 6 to ≤ 36 months at risk of anaemia by measuring Total Haemoglobin (SpHb) using a non-invasive haemoglobin assessment. Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- measuring Total Haemoglobin (SpHb) using Masimo Rad-67.
- How many people
- 1,215 participants
- Where
- 1 siteMalaysia
- Study dates
- 19 Jul 2022to 28 Feb 2023
- Phase
- Observational
- 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 6 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population consists of Malaysian children aged ≥ 6 months to ≤ 36 months seen at Mother and Child Health Clinic (MCHC). A sample size of 1200 will be required after accounting for 10% each of screen failures and dropouts. Any withdrawn subjects /screen failures will be replaced.
Who may be able to join
- Outpatient children aged ≥ 6 months to ≤ 36 months at MCHC accompanied by their primary caretaker who could be parents/ grandparents / relatives.
- Written consent from parent(s) / grandparents / relatives / legally acceptable representative(s) who are the primary caretaker of the child, who themselves are aged ≥18 years, to consent and comply with the terms and conditions of the study.
Who cannot join
- Children with any medical condition that, in the opinion of the Investigator, would not be suitable for enrolment into the study. The examples of such medical condition include: severe chromosome / genetic abnormalities, severe neurological disorders which may cause feeding difficulties, severe congenital heart disease, severe acute malnutrition, gastrointestinal disorders that result in malabsorption (e.g. coeliac disease), malignancies, and any other medical condition in which the Investigator considers that interventions to increase nutritional intake may not be effective in improving weight gain and nutritional status.
- Children participating in any other studies involving iron fortified foods / supplementation.
- Parent(s) / legally acceptable representative(s) who have insufficient ability to understand or communicate in English and / or Bahasa Malaysia and / or Chinese (Mandarin).
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Department of Paediatrics, University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
About this study
Official title: A Cross- Sectional Study on the Prevalence of Malaysian Children Aged ≥ 6 to ≤ 36 Months at Risk of Anaemia
The main purpose of this study is to determine the prevalence of Malaysian children aged ≥ 6 to ≤ 36 months at risk of anaemia by measuring Total Haemoglobin (SpHb) using a non-invasive haemoglobin assessment. Eligible subjects, and their parent(s) / legally acceptable representative(s) where applicable, who fulfil all the inclusion and none of the exclusion criteria will be enrolled into the study. Parameters will be recorded during the subjects visit at the MCHC using a self-administered 24-hour Diet Recall. Demographics and subject / family characteristics will be recorded at this visit by using questionnaire built into Iron Strong app which act as a data collection tool.For subjects with haemoglobin level <12 g/dL, the subject will be considered "at risk of anaemia" and as a standard operating procedure, the child will be referred to HCPs for further clinical assessment.
Read the detailed description
Eligible subjects, and their parent(s) / legally acceptable representative(s) where applicable, who fulfil all the inclusion and none of the exclusion criteria will be enrolled into the study. Recruitment at the study sites will continue until required number subjects have been enrolled.
Parameters will be recorded during the subjects visit at the MCHC. Parent(s) / legally acceptable representative(s) will be asked to report subject dietary intake using a self-administered 24-hour Diet Recall. A Site Research Assistant will be present to assist with the completion of the 24-hour Diet Recall.
Demographics and subject / family characteristics will be recorded at this visit by using questionnaire built into Iron Strong app. The Iron Strong app, as a data collection tool includes an optical character recognition (OCR) model that allows user (by taking a picture) to accurately predicts all units and digits on Masimo Rad-67 device and store the data within the app / server. The access of the application is only possible via email invitation to Site Investigator / Research Assistant.
Masimo Rad-67 is a non-invasive device for total haemoglobin screening. A clip with sensor attached to Masimo Rad-67 will be place on the child's finger / toe, reading will take approximately 30 seconds.
For subjects with haemoglobin level <12 g/dL, the subject will be considered "at risk of anaemia" and as a standard operating procedure, the child will be referred to HCPs for further clinical assessment.
- Conditions
- Anemia
- Being tested
- measuring Total Haemoglobin (SpHb) using Masimo Rad-67.
- Keywords
- anaemia, paediatrics
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measuring Total Haemoglobin (SpHb) using Masimo Rad-67.Diagnostic test
To determine the prevalence of Malaysian children aged ≥ 6 to ≤ 36 months at risk of anaemia by measuring Total Haemoglobin (SpHb) using Masimo Rad-67.
| Study group | Role | What they receive |
|---|---|---|
| Malaysian children aged ≥ 6 months to ≤ 36 months | The study population consists of Malaysian children aged ≥ 6 months to ≤ 36 months seen at Mother and Child Health Clinic (MCHC). Receives: Diagnostic Test: measuring Total Haemoglobin (SpHb) using Masimo Rad-67. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Malaysian Children aged ≥ 6 to ≤ 36 months with SpHb (g/dL) <12 g/dL vs ≥12 g/dL measured using Masimo Rad-67.
Percentage of Malaysian Children aged ≥ 6 to ≤ 36 months with SpHb (g/dL) <12 g/dL vs ≥12 g/dL measured using Masimo Rad-67.
Measured: 6 months
Secondary outcomes (5)
Mean Haemoglobin among Malaysian children aged ≥ 6 to ≤ 36 months. Proportion of Malaysia children aged ≥ 6 to ≤ 36 months with SpHb (g/dL) < 11g/dL vs ≥11g/dL measured using Masimo Rad-67.
Mean Haemoglobin among Malaysian children aged ≥ 6 to ≤ 36 months. Proportion of Malaysia children aged ≥ 6 to ≤ 36 months with SpHb (g/dL) < 11g/dL vs ≥11g/dL measured using Masimo Rad-67.
Measured: 6 months
Socio-demographic characteristics of child and parent(s) assisted and administered by Site Investigator.
Socio-demographic characteristics of child and parent(s) assisted and administered by Site Investigator.
Measured: 6 months
Dietary intake using self-administered 24-hour Diet Recall interviewed and recorded by RA / Site Investigator.
Dietary intake using self-administered 24-hour Diet Recall interviewed and recorded by RA / Site Investigator.
Measured: 6 months
Height / Length & weight recorded by RA / Site Investigator for their corresponding WHO Weight for Age, Height for Age Z-Scores for data analysis.
Height / Length \& weight recorded by RA / Site Investigator for their corresponding WHO Weight for Age, Height for Age Z-Scores for data analysis.
Measured: 6 months
Correlation between nutritional status (WHO Z-Scores, Total Energy intake / day, Protein intake / day, Iron intake / day) and risk of anaemia among Malaysian children aged ≥ 6 to ≤ 36 months.
Correlation between nutritional status (WHO Z-Scores, Total Energy intake / day, Protein intake / day, Iron intake / day) and risk of anaemia among Malaysian children aged ≥ 6 to ≤ 36 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start19 Jul 2022
- Primary completion2 Dec 2022
- 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 AnemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Specialized Nutrition (M) Sdn Bhd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Muhammad Yazid Jalaludin, Principal investigator, Department of Paediatrics, University Malaya Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181436
- Sponsor's protocol ID
- MD21-002
- Status last verified
- Dec 2022
- First submitted
- 20 Dec 2021
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This study is an industry sponsored research. Danone Specialized Nutrition (Malaysia) Sdn Bhd being the sponsor of the research is the exclusive owner of the study data as mutually agreed in the Clinical Trial Agreement. Investigators can be part of publication team and author of the manuscript as mutually agreed in the Clinical Trial Agreement. Proposals from Investigators for access to additional study data research,manuscript writing, knowledge sharing, reporting to ministries etc purposes can be given with permission by Danone Malaysia when applicable.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross- Sectional Study on the Prevalence of Malaysian Children Aged ≥ 6 to ≤ 36 Months at Risk of Anaemia
- ClinicalTrials.gov ID
- NCT05181436
- Acronym / sponsor ID
- MD21-002
- Conditions
- Anemia
- Keywords
- anaemia, paediatrics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,215 participants (actual)
- Lead sponsor
- Danone Specialized Nutrition (M) Sdn BhdIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 6 Jan 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 main purpose of this study is to determine the prevalence of Malaysian children aged ≥ 6 to ≤ 36 months at risk of anaemia by measuring Total Haemoglobin (SpHb) using a non-invasive haemoglobin assessment. Eligible subjects, and their parent(s) / legally acceptable representative(s) where applicable, who fulfil all the inclusion and none of the exclusion criteria will be enrolled into the study. Parameters will be recorded during the subjects visit at the MCHC using a self-administered 24-hour Diet Recall. Demographics and subject / family characteristics will be recorded at this visit by using questionnaire built into Iron Strong app which act as a data collection tool.For subjects with haemoglobin level <12 g/dL, the subject will be considered "at risk of anaemia" and as a standard operating procedure, the child will be referred to HCPs for further clinical assessment.
Detailed description
Eligible subjects, and their parent(s) / legally acceptable representative(s) where applicable, who fulfil all the inclusion and none of the exclusion criteria will be enrolled into the study. Recruitment at the study sites will continue until required number subjects have been enrolled.
Parameters will be recorded during the subjects visit at the MCHC. Parent(s) / legally acceptable representative(s) will be asked to report subject dietary intake using a self-administered 24-hour Diet Recall. A Site Research Assistant will be present to assist with the completion of the 24-hour Diet Recall.
Demographics and subject / family characteristics will be recorded at this visit by using questionnaire built into Iron Strong app. The Iron Strong app, as a data collection tool includes an optical character recognition (OCR) model that allows user (by taking a picture) to accurately predicts all units and digits on Masimo Rad-67 device and store the data within the app / server. The access of the application is only possible via email invitation to Site Investigator / Research Assistant.
Masimo Rad-67 is a non-invasive device for total haemoglobin screening. A clip with sensor attached to Masimo Rad-67 will be place on the child's finger / toe, reading will take approximately 30 seconds.
For subjects with haemoglobin level <12 g/dL, the subject will be considered "at risk of anaemia" and as a standard operating procedure, the child will be referred to HCPs for further clinical assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Malaysian children aged ≥ 6 months to ≤ 36 months | – | Diagnostic Test: measuring Total Haemoglobin (SpHb) using Masimo Rad-67.The study population consists of Malaysian children aged ≥ 6 months to ≤ 36 months seen at Mother and Child Health Clinic (MCHC). |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population consists of Malaysian children aged ≥ 6 months to ≤ 36 months seen at Mother and Child Health Clinic (MCHC). A sample size of 1200 will be required after accounting for 10% each of screen failures and dropouts. Any withdrawn subjects /screen failures will be replaced.
Key inclusion criteria (2 listed)
- Outpatient children aged ≥ 6 months to ≤ 36 months at MCHC accompanied by their primary caretaker who could be parents/ grandparents / relatives.
- Written consent from parent(s) / grandparents / relatives / legally acceptable representative(s) who are the primary caretaker of the child, who themselves are aged ≥18 years, to consent and comply with the terms and conditions of the study.
Key exclusion criteria (3 listed)
- Children with any medical condition that, in the opinion of the Investigator, would not be suitable for enrolment into the study. The examples of such medical condition include: severe chromosome / genetic abnormalities, severe neurological disorders which may cause feeding difficulties, severe congenital heart disease, severe acute malnutrition, gastrointestinal disorders that result in malabsorption (e.g. coeliac disease), malignancies, and any other medical condition in which the Investigator considers that interventions to increase nutritional intake may not be effective in improving weight gain and nutritional status.
- Children participating in any other studies involving iron fortified foods / supplementation.
- Parent(s) / legally acceptable representative(s) who have insufficient ability to understand or communicate in English and / or Bahasa Malaysia and / or Chinese (Mandarin).
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 |
|---|---|---|
| measuring Total Haemoglobin (SpHb) using Masimo Rad-67.To determine the prevalence of Malaysian children aged ≥ 6 to ≤ 36 months at risk of anaemia by measuring Total Haemoglobin (SpHb) using Masimo Rad-67. | Diagnostic test | Malaysian children aged ≥ 6 months to ≤ 36 months |
Primary outcome
Percentage of Malaysian Children aged ≥ 6 to ≤ 36 months with SpHb (g/dL) <12 g/dL vs ≥12 g/dL measured using Masimo Rad-67.
Time frame: 6 months
Percentage of Malaysian Children aged ≥ 6 to ≤ 36 months with SpHb (g/dL) <12 g/dL vs ≥12 g/dL measured using Masimo Rad-67.
5 secondary outcomes
Mean Haemoglobin among Malaysian children aged ≥ 6 to ≤ 36 months. Proportion of Malaysia children aged ≥ 6 to ≤ 36 months with SpHb (g/dL) < 11g/dL vs ≥11g/dL measured using Masimo Rad-67.
Time frame: 6 months
Socio-demographic characteristics of child and parent(s) assisted and administered by Site Investigator.
Time frame: 6 months
Dietary intake using self-administered 24-hour Diet Recall interviewed and recorded by RA / Site Investigator.
Time frame: 6 months
Height / Length & weight recorded by RA / Site Investigator for their corresponding WHO Weight for Age, Height for Age Z-Scores for data analysis.
Time frame: 6 months
Correlation between nutritional status (WHO Z-Scores, Total Energy intake / day, Protein intake / day, Iron intake / day) and risk of anaemia among Malaysian children aged ≥ 6 to ≤ 36 months.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Individual participant dataSharing planned: No. This study is an industry sponsored research. Danone Specialized Nutrition (Malaysia) Sdn Bhd being the sponsor of the research is the exclusive owner of the study data as mutually agreed in the Clinical Trial Agreement. Investigators can be part of publication team and author of the manuscript as mutually agreed in the Clinical Trial Agreement. Proposals from Investigators for access to additional study data research,manuscript writing, knowledge sharing, reporting to ministries etc purposes can be given with permission by Danone Malaysia when applicable.
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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.
Muhammad Yazid Jalaludin principal investigator
Department of Paediatrics, University Malaya Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by Danone Specialized Nutrition (M) Sdn Bhd at 1 site in Malaysia.
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 2 inclusion and 3 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 22 Dec 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 Malaysia. 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?
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?
Percentage of Malaysian Children aged ≥ 6 to ≤ 36 months with SpHb (g/dL) <12 g/dL vs ≥12 g/dL measured using Masimo Rad-67. (time frame: 6 months). 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 22 Dec 2022.