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

NCT01715038 | Completed

• 2 other identifiers: 252233PR-10044
• Study Type: interventional
• Target: 4,011
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition

Keywords

malnutrition; stunting; LNS; micronutrient powder; hemoglobin

Outcome Measures

Primary Outcomes (3)

• Birth weight

  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.

  Within 48 hours (or back calculated from later measurements).

• Birth length

  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.

  Within 48 hours (or back calculated from later measurements)

• Child linear growth status at 24 months

  Linear 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.

  24 months

Secondary Outcomes (27)

• Change in maternal weight between baseline and 36 wk gestation

  Between 12-20 and 36 weeks of gestation

• Pre-eclampsia

  36 weeks of gestation

• Duration of gestation

  Day 0

• Pre-term delivery

  Day 0

• Low birth weight

  Within 48 hours (or back calculated from later measurements)

Other Outcomes (7)

• Change in maternal hemoglobin concentration between baseline and 36 wk gestation

  Between 12-20 weeks and 36 weeks of gestation

• Change in maternal iodine status between baseline and 36 wk gestation

  Between 12-20 weeks and 36 weeks of gestation

• Change in maternal depressive symptoms between baseline and 36 wk gestation

  Between 12-20 weeks and 36 weeks of gestation

Study Arms (4)

Comprehensive

EXPERIMENTAL

"Comprehensive" LNS: LNS-PLW provided daily to mothers during pregnancy and postpartum lactation (a total of at least 11 months, starting by 20 weeks gestation and ending at 6 months post-partum) and LNS developed for infants and young children (LNS-child) provided daily to their infants (beginning at 6 months of age for a period of 18 months i.e., from 6-24 months of age).

Dietary Supplement: LNS-PLW; Dietary Supplement: LNS-Child

Child-only LNS

EXPERIMENTAL

"Child-only" LNS: Daily LNS-child supplementation of the child starting at 6 months of age and ending at 24 months of age (18 months total). Women will be provided with iron and folic acid (IFA) tablets during pregnancy and for 3 months postpartum.

Dietary Supplement: LNS-Child; Dietary Supplement: IFA

Child-only MNP

EXPERIMENTAL

"Child-only" MNP: Daily MNP supplementation of the child starting at 6 months of age and ending at 24 months of age (18 months total). Women will be provided with iron and folic acid (IFA) tablets during pregnancy and for 3 months postpartum.

Dietary Supplement: MNP; Dietary Supplement: IFA

Control: IFA

ACTIVE COMPARATOR

Control: No additional nutrient supplementation for the child will be provided through the study, but the regular nutrition education and visits provided by the program frontline staff will continue. Women will be provided with iron and folic acid (IFA) tablets during pregnancy and for 3 months postpartum.

Dietary Supplement: IFA

Interventions

LNS-PLW DIETARY_SUPPLEMENT

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

Comprehensive

LNS-Child DIETARY_SUPPLEMENT

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

Child-only LNS; Comprehensive

MNP DIETARY_SUPPLEMENT

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.

Child-only MNP

IFA DIETARY_SUPPLEMENT

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

Child-only LNS; Child-only MNP; Control: IFA

Eligibility Criteria

• Age: 6 Months - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead
• Family Health International 360: collaborator
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• LAMB Project: collaborator

Study Sites (1)

LAMB

Parbatipur, Rangpur and Dinajpur Districts, Bangladesh

Location

Related Publications (13)

• 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.

  PMID: 35584874 DERIVED

• 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.

  PMID: 31656181 DERIVED

• 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.

  PMID: 31162588 DERIVED

• 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.

  PMID: 30204885 DERIVED

• 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.

  PMID: 29901736 DERIVED

• 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.

  PMID: 28978680 DERIVED

• 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.

  PMID: 28724657 DERIVED

• 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.

  PMID: 28615379 DERIVED

• 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.

  PMID: 28275128 DERIVED

• 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.

  PMID: 28275125 DERIVED

• 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.

  PMID: 27440259 DERIVED

• 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.

  PMID: 26898720 DERIVED

• 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.

  PMID: 26607935 DERIVED

MeSH Terms

Conditions

Malnutrition; Growth Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kathryn G Dewey, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 26, 2012
• Study Start: October 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

BA (1)