Clinical trial NCT01715038: Effectiveness of LNS and MNP Supplements to Prevent Malnutrition in Women and Their Children in Bangladesh
Official title: Home-fortification Approaches for the Prevention of Malnutrition in Pregnant and Lactating Women and Their Children in Bangladesh: Program Effectiveness Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: malnutrition
stunting
LNS
micronutrient powder
hemoglobin
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Family Health International 360
name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: World Mission Prayer League (LAMB)
First posted: 2012-10-26
Enrollment: 4011
Sex: ALL
Minimum age (years): 6
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Birth weight
timeFrame: Within 48 hours (or back calculated from later measurements).
measure: Birth length
timeFrame: Within 48 hours (or back calculated from later measurements)
measure: Child linear growth status at 24 months
timeFrame: 24 months
Secondary outcomes:
measure: Change in maternal weight between baseline and 36 wk gestation
timeFrame: Between 12-20 and 36 weeks of gestation
measure: Pre-eclampsia
timeFrame: 36 weeks of gestation
measure: Duration of gestation
timeFrame: Day 0
measure: Pre-term delivery
timeFrame: Day 0
measure: Low birth weight
timeFrame: Within 48 hours (or back calculated from later measurements)
measure: Small for gestational age (SGA)
timeFrame: Within 48 hours (or back calculated from later measurements)
measure: Newborn stunting
timeFrame: Within 48 hours (or back calculated from later measurements)
measure: BMI z score at birth
timeFrame: Within 48 hours (or back calculated from later measurements)
measure: Head circumference (HC) at birth
timeFrame: Within 48 hours (or back calculated from later measurements)
measure: Small head size at birth
timeFrame: Within 48 hours (or back calculated from later measurements)
measure: Change in maternal weight between 42 d and 6 mo postpartum
timeFrame: Between 42 d and 6 mo postpartum
measure: Change in maternal iodine status between baseline and 6 mo postpartum
timeFrame: Between 10-20 weeks of gestation and 6 months postpartum
measure: Change in maternal iron status between baseline and 6 months postpartum
timeFrame: Between 10-20 weeks of gestation and 6 months postpartum
measure: Change in maternal iron-deficiency anemia between baseline and 6 months postpartum
timeFrame: Between 10-20 weeks of gestation and 6 months postpartum
measure: Change in maternal anemia between baseline and 6 months postpartum
timeFrame: Between 10-20 weeks of gestation and 6 months postpartum
measure: Change in maternal vitamin A status between baseline and 6 months postpartum
timeFrame: Between 10-20 weeks of gestation and 6 months postpartum
measure: Change in maternal depressive symptoms between baseline and 6 months postpartum
timeFrame: Between 10-20 weeks of gestation and 6 months postpartum
measure: Child hemoglobin concentration at 18 months of age
timeFrame: 18 months
measure: Child iron status at 18 months of age
timeFrame: 18 months
measure: Child vitamin A status at 18 months of age
timeFrame: 18 months
measure: Child anemia status at 18 months of age
timeFrame: 18 months
measure: Child iron-deficiency anemia status at 18 months of age
timeFrame: 18 months
measure: Wasting at 24 months of age
timeFrame: 24 months
measure: Head circumference at 24 months of age
timeFrame: 24 months
measure: Stunting at 24 months of age
timeFrame: 24 months
measure: Child motor development at 24 months of age
timeFrame: 24 months
measure: Child cognitive development at 24 months of age
timeFrame: 24 months
Other outcomes:
measure: Change in maternal hemoglobin concentration between baseline and 36 wk gestation
timeFrame: Between 12-20 weeks and 36 weeks of gestation
measure: Change in maternal iodine status between baseline and 36 wk gestation
timeFrame: Between 12-20 weeks and 36 weeks of gestation
measure: Change in maternal depressive symptoms between baseline and 36 wk gestation
timeFrame: Between 12-20 weeks and 36 weeks of gestation
measure: Change in maternal iron status between baseline and 36 wk gestation
timeFrame: Between 12-20 weeks and 36 weeks of gestation
measure: Change in maternal vitamin A status between baseline and 36 wk gestation
timeFrame: Between 12-20 weeks and 36 weeks of gestation
measure: Change in maternal anemia between baseline and 36 wk gestation
timeFrame: Between 12-20 weeks and 36 weeks of gestation
measure: Change in maternal iron-deficiency anemia between baseline and 36 wk gestation
timeFrame: Between 12-20 weeks and 36 weeks of gestation
Locations:
city: Parbatipur
country: Bangladesh
facility: LAMB
state: Rangpur and Dinajpur Districts
Study officials:
affiliation: University of California, Davis
name: Kathryn G Dewey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roy A, Hossain MM, Ullah MB, Mridha MK. Maternal and neonatal peripartum factors associated with late initiation of breast feeding in Bangladesh: a secondary analysis. BMJ Open. 2022 May 18;12(5):e051004. doi: 10.1136/bmjopen-2021-051004.
citation: Ullah MB, Mridha MK, Arnold CD, Matias SL, Khan MSA, Siddiqui Z, Hossain M, Paul RR, Dewey KG. Factors associated with diarrhea and acute respiratory infection in children under two years of age in rural Bangladesh. BMC Pediatr. 2019 Oct 27;19(1):386. doi: 10.1186/s12887-019-1738-6.
citation: Ullah MB, Mridha MK, Arnold CD, Matias SL, Khan MSA, Siddiqui Z, Hossain M, Dewey KG. Provision of Pre- and Postnatal Nutritional Supplements Generally Did Not Increase or Decrease Common Childhood Illnesses in Bangladesh: A Cluster-Randomized Effectiveness Trial. J Nutr. 2019 Jul 1;149(7):1271-1281. doi: 10.1093/jn/nxz059.
citation: Matias SL, Mridha MK, Young RT, Hussain S, Dewey KG. Daily Maternal Lipid-Based Nutrient Supplementation with 20 mg Iron, Compared with Iron and Folic Acid with 60 mg Iron, Resulted in Lower Iron Status in Late Pregnancy but Not at 6 Months Postpartum in Either the Mothers or Their Infants in Bangladesh. J Nutr. 2018 Oct 1;148(10):1615-1624. doi: 10.1093/jn/nxy161.
citation: Matias SL, Mridha MK, Young RT, Khan MSA, Siddiqui Z, Ullah MB, Vosti SA, Dewey KG. Prenatal and Postnatal Supplementation with Lipid-Based Nutrient Supplements Reduces Anemia and Iron Deficiency in 18-Month-Old Bangladeshi Children: A Cluster-Randomized Effectiveness Trial. J Nutr. 2018 Jul 1;148(7):1167-1176. doi: 10.1093/jn/nxy078.
citation: Adams KP, Ayifah E, Phiri TE, Mridha MK, Adu-Afarwuah S, Arimond M, Arnold CD, Cummins J, Hussain S, Kumwenda C, Matias SL, Ashorn U, Lartey A, Maleta KM, Vosti SA, Dewey KG. Maternal and Child Supplementation with Lipid-Based Nutrient Supplements, but Not Child Supplementation Alone, Decreases Self-Reported Household Food Insecurity in Some Settings. J Nutr. 2017 Dec;147(12):2309-2318. doi: 10.3945/jn.117.257386. Epub 2017 Oct 4.
citation: Mridha MK, Matias SL, Paul RR, Hussain S, Sarker M, Hossain M, Peerson JM, Vosti SA, Dewey KG. Prenatal Lipid-Based Nutrient Supplements Do Not Affect Pregnancy or Childbirth Complications or Cesarean Delivery in Bangladesh: A Cluster-Randomized Controlled Effectiveness Trial. J Nutr. 2017 Sep;147(9):1776-1784. doi: 10.3945/jn.117.248880. Epub 2017 Jul 19.
citation: Mridha MK, Matias SL, Paul RR, Hussain S, Khan MSA, Siddiqui Z, Ullah B, Sarker M, Hossain M, Young RT, Arnold CD, Dewey KG. Daily Consumption of Lipid-Based Nutrient Supplements Containing 250 mug Iodine Does Not Increase Urinary Iodine Concentrations in Pregnant and Postpartum Women in Bangladesh. J Nutr. 2017 Aug;147(8):1586-1592. doi: 10.3945/jn.117.248963. Epub 2017 Jun 14.
citation: Matias SL, Mridha MK, Tofail F, Arnold CD, Khan MS, Siddiqui Z, Ullah MB, Dewey KG. Home fortification during the first 1000 d improves child development in Bangladesh: a cluster-randomized effectiveness trial. Am J Clin Nutr. 2017 Apr;105(4):958-969. doi: 10.3945/ajcn.116.150318. Epub 2017 Mar 8.
citation: Dewey KG, Mridha MK, Matias SL, Arnold CD, Cummins JR, Khan MS, Maalouf-Manasseh Z, Siddiqui Z, Ullah MB, Vosti SA. Lipid-based nutrient supplementation in the first 1000 d improves child growth in Bangladesh: a cluster-randomized effectiveness trial. Am J Clin Nutr. 2017 Apr;105(4):944-957. doi: 10.3945/ajcn.116.147942. Epub 2017 Mar 8.
citation: Matias SL, Mridha MK, Paul RR, Hussain S, Vosti SA, Arnold CD, Dewey KG. Prenatal Lipid-Based Nutrient Supplements Affect Maternal Anthropometric Indicators Only in Certain Subgroups of Rural Bangladeshi Women. J Nutr. 2016 Sep;146(9):1775-82. doi: 10.3945/jn.116.232181. Epub 2016 Jul 20.
citation: Harding KL, Matias SL, Mridha MK, Moniruzzaman M, Vosti SA, Hussain S, Dewey KG, Stewart CP. Adherence to recommendations on lipid-based nutrient supplement and iron and folic acid tablet consumption among pregnant and lactating women participating in a community health programme in northwest Bangladesh. Matern Child Nutr. 2017 Jan;13(1):e12252. doi: 10.1111/mcn.12252. Epub 2016 Feb 22.
citation: Mridha MK, Matias SL, Chaparro CM, Paul RR, Hussain S, Vosti SA, Harding KL, Cummins JR, Day LT, Saha SL, Peerson JM, Dewey KG. Lipid-based nutrient supplements for pregnant women reduce newborn stunting in a cluster-randomized controlled effectiveness trial in Bangladesh. Am J Clin Nutr. 2016 Jan;103(1):236-49. doi: 10.3945/ajcn.115.111336. Epub 2015 Nov 25.