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Effectiveness of LNS and MNP Supplements to Prevent Malnutrition in Women and Their Children in Bangladesh

Home-fortification Approaches for the Prevention of Malnutrition in Pregnant and Lactating Women and Their Children in Bangladesh: Program Effectiveness Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01715038
Acronym
RDNS
Enrollment
4011
Registered
2012-10-26
Start date
2011-10-31
Completion date
2015-10-31
Last updated
2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

Keywords

malnutrition, stunting, LNS, micronutrient powder, hemoglobin

Brief summary

The program effectiveness study aims to assess the effect of a lipid-based nutrition supplement (LNS) and micronutrient powder (MNP) provided in a programmatic context for improving maternal nutritional status during pregnancy and lactation (LNS only), and preventing malnutrition in infants and young children (LNS and MNP) in Bangladesh.

Detailed description

This study is a cluster-randomized controlled trial with four study arms, implemented within the context of the Community Health and Development Program (CHDP) run by the World Mission Prayer League, which also has a hospital in the area and is known as LAMB. Data collection is longitudinal, starting with the identification of women in early pregnancy who are eligible to enter the study, and continuing, with follow-up of the child, until 24 months post-partum. A final follow-up visit will occur when the child is 36 months old to update contact information; no outcomes data will be collected at that final visit. The investigators are evaluating the effect of providing LNS-PLW to mothers during pregnancy and lactation on maternal health and nutrition outcomes (including anthropometric and micronutrient status), morbidity and birth outcomes in comparison to mothers who receive iron-folic acid tablets during pregnancy and lactation. The investigators are also evaluating the effect of three different home-fortification approaches (arms a-c, below) on child health and nutrition outcomes including anthropometric status, micronutrient status, anemia, and motor and cognitive development, in comparison to a control arm not receiving a home fortification intervention. Additionally, the cost of implementation and delivery of the LNS-PLW, LNS-child or MNP interventions as part of the CHDP compared to standard CHDP program delivery will be documented. Willingness to pay (private demand) for LNS-PLW, LNS-child and MNP products by selected caregivers and male heads of households will be assessed at baseline and again at various points during the intervention period. A process evaluation of the LNS and MNP interventions, and of the services provided to the control group, within the CHDP will be conducted to: 1) Document and evaluate the processes needed for implementation of interventions that provide a nutrient supplement such as LNS or MNP in the context of the CHDP; and 2) Explain and interpret program effectiveness study results and identify important facilitators and barriers to success of the nutrition intervention, which can be used to improve the effectiveness of current CHDP programs and future similar programs that include the scaling-up of LNS or MNP. A post-intervention follow-up assessment for participants in the RDNS trial was added to the study protocol in November 2015. The intervention stopped when the study children turned 24 months old, and follow-up visits to update contact information were conducted when the children turned 36 months old. Thereafter, when the study children are between 40 and 52 months old, the follow-up assessment includes anthropometric and cognitive development assessments and collection of blood samples (finger prick, for measurement of hemoglobin) and buccal swab samples at the local clinics; for the mothers the follow-up includes anthropometric measurements, measurement of blood pressure and collection of fasting blood samples (finger prick). The follow-up also includes anthropometric measurements of the younger siblings, as well as a home visit to collect information on socioeconomic status, food security, hospitalizations of mother or child, developmental stimulation in the home, child food preferences and retrospective perceptions about the trial interventions. Follow-up outcomes: Maternal: Body mass index, skinfold thickness, mid-upper arm circumference, attained height. Hemoglobin, anemia, blood pressure, blood lipids, HbA1C. Index child: Height, HAZ, stunting, weight, WHZ, WAZ, wasting, skinfold thickness, MUAC, arm fat and muscle area. Verbal ability (language), non-verbal ability (visual spatial), executive function and pre-academic skills. Hemoglobin, anemia. Hospitalizations since 24 months of age. Preferences for sweet and fatty foods. Younger sibling: Height, HAZ, stunting, weight, WHZ, WAZ, wasting, MUAC.

Interventions

DIETARY_SUPPLEMENTLNS-PLW

Dietary supplement: Lipid-based nutrient supplement Lipid-based nutrient supplement for pregnant and lactating women (LNS-PLW) Daily dose of LNS-PLW will be 20 g, packaged in one sachet

DIETARY_SUPPLEMENTLNS-Child

Dietary supplement: Lipid-based nutrient supplement Lipid-based nutrient supplement for infants and young children (LNS-Child) Daily dose of LNS-Child will be 20 g, packaged in two 10 g sachets

DIETARY_SUPPLEMENTMNP

Dietary supplement: Micronutrient powder Micronutrient powder for infants and young children (MNP) The MNP for children will be packaged in 1 g sachets, so that each day, the child will consume one sachet.

DIETARY_SUPPLEMENTIFA

Dietary supplement: Iron and folic acid nutrient supplement Iron-folic acid tablets for pregnant and lactating women Daily dose of iron-folic acid supplement will be one tablet containing 60 mg iron and 400 mcg folic acid

Sponsors

Family Health International 360
CollaboratorUNKNOWN
International Centre for Diarrhoeal Disease Research, Bangladesh
CollaboratorOTHER
LAMB Project
CollaboratorOTHER
University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
6 Months to 49 Years
Healthy volunteers
No

Inclusion criteria

* Gestational age ≤ 20 weeks * Planning to remain in the study area during pregnancy and the following three years (i.e., a permanent resident of the study area)

Exclusion criteria

* Pregnancy identified and registered in the CHDP program before the beginning of the enrollment.

Design outcomes

Primary

MeasureTime frameDescription
Birth weightWithin 48 hours (or back calculated from later measurements).Birth weight of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Child linear growth status at 24 months24 monthsLinear growth (the comprehensive LNS approach vs. the child-only LNS approach vs. child-only MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Birth lengthWithin 48 hours (or back calculated from later measurements)Birth length of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.

Secondary

MeasureTime frameDescription
Change in maternal iodine status between baseline and 6 mo postpartumBetween 10-20 weeks of gestation and 6 months postpartumPrevalence of iodine deficiency during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iodine status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Child anemia status at 18 months of age18 monthsPrevalence of anemia in children (the comprehensive LNS approach vs. the child-only LNS approach vs. child-only MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Child iron-deficiency anemia status at 18 months of age18 monthsPrevalence of iron-deficiency anemia in children (the comprehensive LNS approach vs. the child-only LNS approach vs. child-only MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Wasting at 24 months of age24 monthsPrevalence of wasting (weight-for-length z-score \<-2) in children (the comprehensive LNS approach vs. the child-only LNS approach vs. child-only MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Head circumference at 24 months of age24 monthsHead circumference of children (the comprehensive LNS approach vs. the child-only LNS approach vs. child-only MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Stunting at 24 months of age24 monthsPrevalence of stunting (length-for-age z-score \<-2) in children (the comprehensive LNS approach vs. the child-only LNS approach vs. child-only MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Child motor development at 24 months of age24 monthsMotor development of children (the comprehensive LNS approach vs. the child-only LNS approach vs. child-only MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Child cognitive development at 24 months of age24 monthsCognitive development of children (the comprehensive LNS approach vs. the child-only LNS approach vs. child-only MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Change in maternal weight between baseline and 36 wk gestationBetween 12-20 and 36 weeks of gestationGestational weight gain from enrollment (by 20 weeks of gestation) through 36 weeks of gestation (women who received LNS for pregnant and lactating women (LNS-PLW) vs. a comparison group who received the standard care, iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Pre-eclampsia36 weeks of gestationPrevalence of pre-eclampsia (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Duration of gestationDay 0Duration of gestation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Pre-term deliveryDay 0Prevalence of pre-term delivery (delivery at \<37 gestational weeks) in the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Low birth weightWithin 48 hours (or back calculated from later measurements)Prevalence of low birth weight (birth weight \< 2500 g) in the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Small for gestational age (SGA)Within 48 hours (or back calculated from later measurements)Prevalence of SGA (birth weight \< 10th percentile) in the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Newborn stuntingWithin 48 hours (or back calculated from later measurements)Prevalence of newborn stunting (length-for-age z-score \<-2) in the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
BMI z score at birthWithin 48 hours (or back calculated from later measurements)BMI z score at birth (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Head circumference (HC) at birthWithin 48 hours (or back calculated from later measurements)Head circumference at birth of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Small head size at birthWithin 48 hours (or back calculated from later measurements)Prevalence of small head size (HC-z-score \<-2) at birth (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Change in maternal weight between 42 d and 6 mo postpartumBetween 42 d and 6 mo postpartumPostpartum weight change from 42 days through 6 mo postpartum (women who received LNS for pregnant and lactating women (LNS-PLW) vs. a comparison group who received the standard care, iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), for time of year when outcome was assessed
Change in maternal iron status between baseline and 6 months postpartumBetween 10-20 weeks of gestation and 6 months postpartumPrevalence of iron deficiency during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iron status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Change in maternal iron-deficiency anemia between baseline and 6 months postpartumBetween 10-20 weeks of gestation and 6 months postpartumPrevalence of iron-deficiency anemia during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iron status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Change in maternal anemia between baseline and 6 months postpartumBetween 10-20 weeks of gestation and 6 months postpartumPrevalence of anemia during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal anemia status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Change in maternal vitamin A status between baseline and 6 months postpartumBetween 10-20 weeks of gestation and 6 months postpartumPrevalence of vitamin A deficiency during lactation (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal vitamin A status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Change in maternal depressive symptoms between baseline and 6 months postpartumBetween 10-20 weeks of gestation and 6 months postpartumPrevalence of depression during lactation (women who received LNS-PLW vs. a comparison group). Pre-defined tests for interaction will be done for: baseline maternal depression status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Child hemoglobin concentration at 18 months of age18 monthsHemoglobin concentration (the comprehensive LNS approach vs. the child-only LNS approach vs. child-only MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Child iron status at 18 months of age18 monthsPrevalence of iron deficiency (the comprehensive LNS approach vs. the child-only LNS approach vs. child-only MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Child vitamin A status at 18 months of age18 monthsPrevalence of vitamin A deficiency (the comprehensive LNS approach vs. the child-only LNS approach vs. child-only MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.

Other

MeasureTime frameDescription
Change in maternal vitamin A status between baseline and 36 wk gestationBetween 12-20 weeks and 36 weeks of gestationPrevalence of vitamin A deficiency during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal vitamin A status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Change in maternal anemia between baseline and 36 wk gestationBetween 12-20 weeks and 36 weeks of gestationPrevalence of anemia during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal anemia status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Change in maternal iron-deficiency anemia between baseline and 36 wk gestationBetween 12-20 weeks and 36 weeks of gestationPrevalence of iron-deficiency anemia during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iron-deficiency anemia status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Change in maternal iron status between baseline and 36 wk gestationBetween 12-20 weeks and 36 weeks of gestationPrevalence of iron deficiency during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iron status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Change in maternal depressive symptoms between baseline and 36 wk gestationBetween 12-20 weeks and 36 weeks of gestationPrevalence of depression during pregnancy (women who received LNS-PLW vs. a comparison group). Pre-defined tests for interaction will be done for: baseline maternal depression status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Change in maternal iodine status between baseline and 36 wk gestationBetween 12-20 weeks and 36 weeks of gestationPrevalence of iodine deficiency during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal iodine status, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.
Change in maternal hemoglobin concentration between baseline and 36 wk gestationBetween 12-20 weeks and 36 weeks of gestationHemoglobin concentration during pregnancy (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: hemoglobin baseline value, baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment) and time of year when outcome was assessed.

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026