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Status unknownNCT05108454Updated Apr 8, 2022

Multiple Micronutrient Supplementation (MMS) Evaluation Among Bangladeshi Pregnant Women

An observational study in Infant, Low Birth Weight, sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh. Status unknown at 1 site in Bangladesh. Open to female participants aged 15 Years to 49 Years. Per ClinicalTrials.gov, last updated 2022-04-08.

Sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,500
Ages
15 Years to 49 Years
Sex
Female
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Study summary

Maternal nutrition profoundly affects foetal growth, development, and subsequent infant birth weight. Babies with low birth weight (LBW) have an elevated risk of death in infancy and later childhood. A recent systematic review revealed that multiple micronutrient supplementations (MMS) could reduce the risk of LBW by 13% in comparison with iron and folic acid (IFA). Based on this newer evidence, the World Health Organization (WHO) recommended MMS during a pregnancy instead of IFA, with consideration of the country context-specific research. However, little progress is being achieved in ensuring adequate MMS coverage to improve pregnancy outcomes. Based on the WHO recommendation, CIFF awarded the Social Marketing Company (SMC) to set up a sustainable business model with affordable and quality MMS to pregnant women in Bangladesh over a period of 5 years through SMC's pharmacy networks. The investigators propose to develop an evaluation design including both process and outcome evaluation to evaluate the implementation and effect of the MMS by the SMC in Bangladesh. The evaluation study will comprise both process and outcome evaluation, complementing each other. The design will be a quasi-experimental cluster-based open cohort, two-arm, mixed-methods design. The evaluation would take place in 5 divisions of Bangladesh.

Read the detailed description

Background: a. Burden: Maternal nutrition profoundly affects foetal growth, development, and subsequent infant birth weight. Babies with low birth weight (LBW) have an elevated risk of death in infancy. Furthermore, these babies have a higher risk of stunting or linear growth failure and slower mental development in childhood. b. Knowledge gap: A recent systematic review revealed that multiple micronutrient supplementations (MMS) could reduce the risk of LBW by 13% in comparison with iron and folic acid (IFA). Based on this newer evidence, the World Health Organization (WHO) has updated the antenatal nutrition recommendations. Now, MMS is recommended during a pregnancy instead of IFA, with consideration of the country context-specific research. However, little progress is being achieved in ensuring adequate MMS coverage to improve pregnancy outcomes. Furthermore, the MMS tablets are expensive compared to the IFA, which might hinder the uptake of the MMS by the people. c. Relevance: Based on the WHO recommendation, CIFF awarded the Social Marketing Company (SMC) to set up a sustainable business model with affordable and quality MMS to pregnant women in Bangladesh over a period of 5 years through SMC's pharmacy networks. The investigators propose to develop an evaluation design including both process and outcome evaluation to evaluate the implementation and effect of the MMS by the SMC in Bangladesh.

Hypothesis: The prevalence of LBW will be reduced by 5% point in the intervention group compared to the control group by the end of the 5-year program.

Objectives: Outcome evaluation- To evaluate the effectiveness of market-based distribution of MMS intervention on the prevalence of low birth weight (less than 2500 g) in the infants born to women in the intervention area who received the intervention compared to control areas Process evaluation- To measure the fidelity, reach and mechanism of impact of the intervention

Methods: The evaluation study will comprise both process and outcome evaluation, complementing each other. The design will be a quasi-experimental cluster-based open cohort, two-arm, mixed-methods design. The evaluation would take place in 5 divisions of Bangladesh: Barishal, Chattogram, Dhaka, Rajshahi, and Sylhet. For outcome evaluation: Eligible pregnant women will be approached for recruitment with proper consent. Right after recruitment, a baseline data collection will be conducted using a structured questionnaire along with anthropometric measurements. The recruited participants will be followed up until the end of their pregnancy. After successful delivery of a baby, an endpoint data collection will be done along with birth weight measurement of the baby. Data from the control areas will be collected following the same guideline to maintain consistency. The process evaluation will be carried out concurrently to monitor the program activities. This will follow a mixed-method design, including both quantitative and qualitative components. The participants will be recruited from the same area where activity for outcome evaluation will be ongoing. The investigators will focus on the fundamental aspects of process evaluation that includes- (a) understanding the health promotion program and how it is supposed to work, (b) defining the purposes for the process evaluation, and (c) considering program characteristics and context and how these may affect implementation.

Outcome measures/variables: The key variable for outcome evaluation is the measurement of birth weight. Key variables for process evaluation are fidelity, reach, and mechanism of impact of the intervention (MMS).

02

Conditions studied

  • Infant, Low Birth Weight
03

In context

Lead sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh is the lead sponsor of 204 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Pregnant mothers live in either intervention or control areas in any trimester of pregnancy.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Singleton pregnancy identified/reported through ultrasonogram during ANC or other available medical proof
  • Absence of severe malnourishment/known chronic diseases- respiratory illness, hypertension, diabetes, TB, haemoglobinopathy, etc. through self-reporting and available documents
  • Participant willingness to participate
  • Provide at least two mobile numbers to contact
  • The place of delivery has been decided

Exclusion criteria

Exclusion Criteria:

  • Non-pregnant
  • Declined to participate
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Intervention group

    Pregnant women who received MMS from the SMC program

    Drug: Multiple micronutrient supplementation

  • Comparison

    Pregnant women who did not receive MMS

Interventions

  • DrugMultiple micronutrient supplementation

    Multiple Micronutrient Supplements (MMS) is a nutritional supplement for use during pregnancy based on United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) formulation following WHO specification. It contains 15 micronutrients including Iron and Folic Acid (IFA) at dosages that approximate the recommended dietary allowances for pregnancy.

    Also known as: MMS

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What researchers measure

Primary outcomes

  1. Percentage of Low birth weight babies

    Babies born with birth weight less than 2500 grams

    Time frame: November 2021 to June 2024

Secondary outcomes

  1. Percentage of Preterm children

    Babies born less than 37 weeks of gestation

    Time frame: November 2021 to June 2024

  2. Number of pregnant women with MMS side effects, compliance, & adverse perinatal outcomes

    MMS side effects: Any side effects of MMS reported by the pregnant mothers. MMS compliance: Pregnant mothers intake of 180 MMS tablets once a day for 6 months. Adverse perinatal outcomes: Any maternal and child health complication before and after child delivery.

    Time frame: November 2021 to June 2024

  3. Percentages of contact and effective coverage for the intervention group

    Reach and utilization of MMS and compliance of pregnant women who consumed MMS

    Time frame: November 2021 to June 2024

  4. Number of pregnant women with their duration of gestation

    Duration of pregnancy in months among the pregnant women at both intervention and control group

    Time frame: November 2021 to June 2024

07

Study locations

1 of 1 sites recruiting
  • International Centre for Diarrhoeal Disease Research, Bangladesh
    Dhaka, 1212, Bangladesh
    Recruiting
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References and documents

Publications

  • Hossain M, Sanin KI, Haque MA, Mbuya MNN, Ghosh S, Aksari S, Gibson S, Neufeld L, Bipul M, Matubbar S, Rahman MM, Khondker R, Salasibew M, Ahmed T. Evaluating the impact of a countrywide, market-based roll-out of multiple micronutrient supplementation on low birth weight in Bangladesh: protocol for a two-arm, quasi-experimental and mixed-methods evaluation study. BMJ Open. 2022 May 30;12(5):e060230. doi: 10.1136/bmjopen-2021-060230. PubMed 35636782 ↗

Individual participant data

Plan to share: Yes — We will strictly follow the icddr,b's ethical guideline and practice to ensure the confidentiality of information collected through this study. The name and phone number(s) of the respondent will not be included in the data set. All data will be stored in a password-protected PC having access to only selected individual(s) using STATA software in a specified drive. After a specific time, data be backed up in three places such as another drive in the same computer, in a PI's computer, and in an additional hard drive which will be placed in a secured location. The information collected from this study may be shared with other researchers if needed only for research purposes, however, it will be strictly followed to maintain confidentiality and privacy and as per the icddr,b's data access policy.

Supporting information: Study protocol, Statistical analysis plan

Time frame: After the study completes.

Access criteria: icddr,b study investigators.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05108454
Collaborators
Children's Investment Fund Foundation
Responsible party
Sponsor
First posted
Nov 5, 2021
Start date
Dec 15, 2021
Primary completion
Jun 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Apr 8, 2022

Study contacts

Muttaquina Hossain, MPH
Contact
muttaquina@icddrb.org
+88-01923758956
Kazi Istiaque Sanin, MPH
Contact
Muttaquina Hossain, MPH
principal investigator · International Centre for Diarrhoeal Disease Research, Bangladesh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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