Iron-deficiencyCUPIPNCT03819530
Child of Urban Poverty Iron Project (CUPIP) - A Pilot Study
A study testing Vitamin and Mineral Powder in people with Iron-deficiency and Iron Deficiency Anemia, run by University of Malaya at 1 site in Malaysia.
Trial summary
The first 1,000 days of life are critical periods for brain development. Proper nutrition lays the foundation for optimal growth, health, and neurodevelopment across the lifespan. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Iron-deficiency, Iron Deficiency Anemia, Micronutrient Deficiency
- What is being tested?
- Vitamin and Mineral Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteMalaysia
- Study dates
- 16 Sep 2019to 15 Mar 2020
- 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 months to 5 years living in PPR Lembah Subang
Who cannot join
- Ex-premature babies and children with congenital abnormalities resulting in gross impairment
- Children whose caregiver did not consent to participation
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University of Malaya Medical Center
Kuala Lumpur, Kuala Lumpur, 59100
About this study
Official title: A Pilot Study of Micronutrient Supplementation for Child of Urban Poverty Iron Project in Selangor, Malaysia
The first 1,000 days of life are critical periods for brain development. Proper nutrition lays the foundation for optimal growth, health, and neurodevelopment across the lifespan. Poor nutrition in this vulnerable period has irreversible consequences, including stunting, susceptibility to sickness, reduced school performance and productivity, and impaired intellectual and social development. UNICEF reported in 2018 that among the low cost flat residents in urban areas of the Klang Valley, 15% of children under 5 years old were stunted, 22% underweight, and 23% either overweight or obese.
Will a micronutrient supplementation program improve the growth and iron status of children aged 6 months to 5 years staying in Lembah Subang? Children will be randomized into treatment and control groups. Treatment groups will receive dietary micronutrient supplementation packets. Measurements of height and weight and iron status will be taken at baseline and 4 months later.
Read the detailed description
This is a pilot study in a single-centre, using a single-blind, two-parallel group, randomized trial conducted amongst children aged 6 months to 5 years residing at PPR Lembah Subang, located in the state of Selangor, Malaysia between October 2019 and February 2020 (4 months). The participants were randomly assigned in a 3:2 treatment-to-control allocation to receive, in addition to the baseline deworming treatment, either daily micronutrient packets for 4 months (intervention arm) or no micronutrient supplementation (control group). This residency area comprises a local population with mixed ethnic makeup and poor socioeconomic status (majority are B40).
We distributed flyers, posters, and leaflets with the help of the community mothers in PPR communities to encourage participation. Registration, informed consent and anthropometric measurements, dietary logs and blood drawn for iron status were taken prior to randomization. All children received a baseline deworming treatment at this point.
The treatment group received baseline deworming medications, a 4-month supply of daily micronutrient supplementation and a compliance monitoring log. The control group only received similar baseline deworming medications without any daily micronutrient supplementation. Only the research investigators and outcome assessors were masked to the treatment status whilst the participants and interventionists research investigators were aware of the assigned intervention.
Primary endpoints assessed in this study are changes in serum ferritin and hemoglobin levels at 0 and 4 months after interventions. The secondary endpoints are changes in age-and-sex standardized height and weight percentile scores at 0 and 4 months after micronutrient supplementation.
- Conditions
- Iron-deficiency, Iron Deficiency Anemia, Micronutrient Deficiency, Nutrient Deficiency, Stunting
- Being tested
- Vitamin and Mineral Powder
- Medical subject headings
- Anemia, Iron-Deficiency, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin and Mineral PowderDietary supplement
Also called Multiple Micronutrient Powder
Vitamin and mineral nutritional supplement. Each packet is 1g of powder, to be taken with food.
| Study group | Role | What they receive |
|---|---|---|
| Supplementation Group | Experimental | Receives baseline deworming medication. Intervention: receive daily micronutrient supplementation packets- 4 month supply, to be taken every day. Blood iron and anthropometric measurements taken at 0 and 4 months. Receives: Dietary Supplement: Vitamin and Mineral Powder |
| Control Group | No intervention | Receives baseline deworming medication. Blood iron and anthropometric measurements taken at 0 and 4 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum ferritin level between baseline and after 4 months mineral supplementation
Blood test for serum ferritin level will be done at enrollment (0 months) and again at end of study period, after 4 months of supplementation (or no supplementation for control group).
Measured: First blood test upon enrollment, at 0 months. Second blood test at 4 months
Change in reticulocyte hemoglobin level between baseline and after 4 months mineral supplementation
Blood test for RET-He level will be done at enrollment (0 months) and again at end of study period, after 4 months of supplementation (or no supplementation for control group).
Measured: First blood test upon enrollment, at 0 months. Second blood test at 4 months
Change in C-reactive protein level between baseline and after 4 months mineral supplementation
Blood test for C-reactive protein level will be done at enrollment (0 months) and again at end of study period, after 4 months of supplementation (or no supplementation for control group).
Measured: First blood test upon enrollment, at 0 months. Second blood test at 4 months
Secondary outcomes (2)
Change in height (cm)
Height of child will be measured at baseline (0 months) and after 4 months mineral supplementation (or no supplementation for control group).
Measured: First height measurement upon enrollment at 0 months. Second height measurement at 6 months.
Change in weight (kg)
Weight of child will be measured at baseline (0 months) and after 4 months mineral supplementation (or no supplementation for control group).
Measured: First weight measurement upon enrollment at 0 months. Second weight measurement at 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start16 Sep 2019
- Primary completion29 Feb 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- More trials run by University of MalayaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment group: receives baseline deworming medication and daily micronutrient supplementation for 4 months; Control group: receives baseline deworming medication only
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucy Chai See Lum, MD, Principal investigator, University Malaya, Faculty of Medic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819530
- Sponsor's protocol ID
- 20181056741
- Acronym
- CUPIP
- Status last verified
- Aug 2022
- First submitted
- 15 Jan 2019
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planning to share patient data.
Publications
Wang CC, Abdul Jalal MI, Song ZL, Teo YP, Tan CA, Heng KV, Low MSY, Anuar Zaini A, Lum LCS. A Randomized Pilot Trial of Micronutrient Supplementation for Under-5 Children in an Urban Low-Cost Flat Community in Malaysia: A Framework for Community-Based Research Integration. Int J Environ Res Public Health. 2022 Oct 25;19(21):13878. doi: 10.3390/ijerph192113878.
PubMed 36360757
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Micronutrient Supplementation for Child of Urban Poverty Iron Project in Selangor, Malaysia
- ClinicalTrials.gov ID
- NCT03819530
- Acronym / sponsor ID
- CUPIP / 20181056741
- Conditions
- Iron-deficiency, Iron Deficiency Anemia, Micronutrient Deficiency, Nutrient Deficiency, Stunting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 28 Jan 2019 (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 first 1,000 days of life are critical periods for brain development. Proper nutrition lays the foundation for optimal growth, health, and neurodevelopment across the lifespan. Poor nutrition in this vulnerable period has irreversible consequences, including stunting, susceptibility to sickness, reduced school performance and productivity, and impaired intellectual and social development. UNICEF reported in 2018 that among the low cost flat residents in urban areas of the Klang Valley, 15% of children under 5 years old were stunted, 22% underweight, and 23% either overweight or obese.
Will a micronutrient supplementation program improve the growth and iron status of children aged 6 months to 5 years staying in Lembah Subang? Children will be randomized into treatment and control groups. Treatment groups will receive dietary micronutrient supplementation packets. Measurements of height and weight and iron status will be taken at baseline and 4 months later.
Detailed description
This is a pilot study in a single-centre, using a single-blind, two-parallel group, randomized trial conducted amongst children aged 6 months to 5 years residing at PPR Lembah Subang, located in the state of Selangor, Malaysia between October 2019 and February 2020 (4 months). The participants were randomly assigned in a 3:2 treatment-to-control allocation to receive, in addition to the baseline deworming treatment, either daily micronutrient packets for 4 months (intervention arm) or no micronutrient supplementation (control group). This residency area comprises a local population with mixed ethnic makeup and poor socioeconomic status (majority are B40).
We distributed flyers, posters, and leaflets with the help of the community mothers in PPR communities to encourage participation. Registration, informed consent and anthropometric measurements, dietary logs and blood drawn for iron status were taken prior to randomization. All children received a baseline deworming treatment at this point.
The treatment group received baseline deworming medications, a 4-month supply of daily micronutrient supplementation and a compliance monitoring log. The control group only received similar baseline deworming medications without any daily micronutrient supplementation. Only the research investigators and outcome assessors were masked to the treatment status whilst the participants and interventionists research investigators were aware of the assigned intervention.
Primary endpoints assessed in this study are changes in serum ferritin and hemoglobin levels at 0 and 4 months after interventions. The secondary endpoints are changes in age-and-sex standardized height and weight percentile scores at 0 and 4 months after micronutrient supplementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment group: receives baseline deworming medication and daily micronutrient supplementation for 4 months; Control group: receives baseline deworming medication only
| Arm | Type | Receives |
|---|---|---|
| Supplementation Group | Experimental | Dietary Supplement: Vitamin and Mineral PowderReceives baseline deworming medication. Intervention: receive daily micronutrient supplementation packets- 4 month supply, to be taken every day. Blood iron and anthropometric measurements taken at 0 and 4 months. |
| Control Group | No intervention | –Receives baseline deworming medication. Blood iron and anthropometric measurements taken at 0 and 4 months. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 6 months to 5 years living in PPR Lembah Subang
Key exclusion criteria (2 listed)
- Ex-premature babies and children with congenital abnormalities resulting in gross impairment
- Children whose caregiver did not consent to participation
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 |
|---|---|---|
| Vitamin and Mineral PowderAlso: Multiple Micronutrient PowderVitamin and mineral nutritional supplement. Each packet is 1g of powder, to be taken with food. | Dietary supplement | Supplementation Group |
Primary outcome
Change in serum ferritin level between baseline and after 4 months mineral supplementation
Time frame: First blood test upon enrollment, at 0 months. Second blood test at 4 months
Blood test for serum ferritin level will be done at enrollment (0 months) and again at end of study period, after 4 months of supplementation (or no supplementation for control group).
Change in reticulocyte hemoglobin level between baseline and after 4 months mineral supplementation
Time frame: First blood test upon enrollment, at 0 months. Second blood test at 4 months
Blood test for RET-He level will be done at enrollment (0 months) and again at end of study period, after 4 months of supplementation (or no supplementation for control group).
Change in C-reactive protein level between baseline and after 4 months mineral supplementation
Time frame: First blood test upon enrollment, at 0 months. Second blood test at 4 months
Blood test for C-reactive protein level will be done at enrollment (0 months) and again at end of study period, after 4 months of supplementation (or no supplementation for control group).
2 secondary outcomes
Change in height (cm)
Time frame: First height measurement upon enrollment at 0 months. Second height measurement at 6 months.
Change in weight (kg)
Time frame: First weight measurement upon enrollment at 0 months. Second weight measurement at 4 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Derived from this study: PubMed 36360757Wang CC, Abdul Jalal MI, Song ZL, Teo YP, Tan CA, Heng KV, Low MSY, Anuar Zaini A, Lum LCS. A Randomized Pilot Trial of Micronutrient Supplementation for Under-5 Children in an Urban Low-Cost Flat Community in Malaysia: A Framework for Community-Based Research Integration. Int J Environ Res Public Health. 2022 Oct 25;19(21):13878. doi: 10.3390/ijerph192113878.
- Individual participant dataSharing planned: No. Not planning to share patient data.
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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.
Lucy Chai See Lum, MD principal investigator
University Malaya, Faculty of Medic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin and Mineral Powder in people with Iron-deficiency and Iron Deficiency Anemia, run by University of Malaya 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 1 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: finished, as of the sponsor's last update on 31 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 serum ferritin level between baseline and after 4 months mineral supplementation (time frame: First blood test upon enrollment, at 0 months. Second blood test at 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03819530, which also lists 1 linked publication.
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 31 Aug 2022.