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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Family Health International 360
International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B)
World Mission Prayer League (LAMB)
Information provided by (Responsible Party):
Kathryn Dewey, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01715038
First received: October 18, 2012
Last updated: October 23, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Malnutrition
Dietary Supplement: LNS-PLW
Dietary Supplement: LNS-Child
Dietary Supplement: MNP
Dietary Supplement: IFA

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Home-fortification Approaches for the Prevention of Malnutrition in Pregnant and Lactating Women and Their Children in Bangladesh: Program Effectiveness Study

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Change in maternal weight between baseline and 36 wk gestation [ Time Frame: Between 12-20 and 36 weeks of gestation ] [ Designated as safety issue: No ]
    Gestational 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)

  • Birth weight [ Time Frame: Within 48 hours ] [ Designated as safety issue: No ]
    Birth weight of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets)

  • Change in maternal hemoglobin concentration between baseline and 36 wk gestation [ Time Frame: Between 12-20 weeks and 36 weeks of gestation ] [ Designated as safety issue: No ]
    Hemoglobin concentration during pregnancy (women who received LNS-PLW vs. women who received iron-folic acid tablets)

  • Linear growth in infant [ Time Frame: 6 months - 18 months ] [ Designated as safety issue: No ]
    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

  • Change in infant hemoglobin concentration between 6 and 18 months of age [ Time Frame: 6 months - 18 months ] [ Designated as safety issue: No ]
    Hemoglobin 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

  • Child motor development at 18 months of age [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Motor 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

  • Child cognitive development at 18 months of age [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Cognitive 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

  • Birth length [ Time Frame: Within 48 hours ] [ Designated as safety issue: No ]
    Birth length of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets)


Secondary Outcome Measures:
  • Duration of gestation [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Duration of gestation (women who received LNS-PLW vs. women who received iron and folic acid tablets)

  • Pre-eclampsia [ Time Frame: 36 weeks of gestation ] [ Designated as safety issue: No ]
    Prevalence of pre-eclampsia (women who received LNS-PLW vs. women who received iron and folic acid tablets)

  • Change in maternal iodine status between baseline and 36 wk gestation [ Time Frame: Between 12-20 weeks and 36 weeks of gestation ] [ Designated as safety issue: No ]
    Prevalence of iodine deficiency during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets)

  • Change in maternal depressive symptoms between baseline and 36 wk gestation [ Time Frame: Between 12-20 weeks and 36 weeks of gestation ] [ Designated as safety issue: No ]
    Prevalence of depression during pregnancy (women who received LNS-PLW vs. a comparison group)

  • Change in maternal iron status between baseline and 36 wk gestation [ Time Frame: Between 12-20 weeks and 36 weeks of gestation ] [ Designated as safety issue: No ]
    Iron deficiency during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets)

  • Change in child iodine status between 6 and 18 months of age [ Time Frame: 6 - 18 months ] [ Designated as safety issue: No ]
    Prevalence of iodine 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

  • Change in child iron status between 6 and 18 months of age [ Time Frame: 6 - 18 months ] [ Designated as safety issue: No ]
    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

  • Change in maternal vitamin A status between baseline and 36 wk gestation [ Time Frame: Between 12-20 weeks and 36 weeks of gestation ] [ Designated as safety issue: No ]
    Prevalence of vitamin A deficiency during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets)

  • Change in child vitamin A status between 6 and 18 months of age [ Time Frame: 6 - 18 months ] [ Designated as safety issue: No ]
    Prevalence 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

  • Change in maternal anemia between baseline and 36 wk gestation [ Time Frame: Between 12-20 weeks and 36 weeks of gestation ] [ Designated as safety issue: No ]
    Anemia during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets)

  • Change in maternal iron-deficiency anemia between baseline and 36 wk gestation [ Time Frame: Between 12-20 weeks and 36 weeks of gestation ] [ Designated as safety issue: No ]
    Iron-deficiency anemia during pregnancy (women who received LNS-PLW vs. women who received iron and folic acid tablets)

  • Change in child anemia between 6 and 18 months of age [ Time Frame: 6 - 18 months ] [ Designated as safety issue: No ]
    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

  • Change in child iron-deficiency anemia between 6 and 18 months of age [ Time Frame: 6 - 18 months ] [ Designated as safety issue: No ]
    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


Enrollment: 4011
Study Start Date: October 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Comprehensive
"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: 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 Supplement: LNS-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

Experimental: Child-only LNS
"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: 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 Supplement: IFA

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

Experimental: Child-only MNP
"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: 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 Supplement: IFA

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

Active Comparator: Control: IFA
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

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


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. 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.

  Eligibility

Ages Eligible for Study:   6 Months to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715038

Locations
Bangladesh
LAMB
Parbatipur, Rangpur and Dinajpur Districts, Bangladesh
Sponsors and Collaborators
University of California, Davis
Family Health International 360
International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B)
World Mission Prayer League (LAMB)
Investigators
Principal Investigator: Kathryn G Dewey, PhD University of California, Davis
  More Information

No publications provided

Responsible Party: Kathryn Dewey, Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT01715038     History of Changes
Other Study ID Numbers: 252233, PR-10044
Study First Received: October 18, 2012
Last Updated: October 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
malnutrition
stunting
LNS
micronutrient powder
hemoglobin

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Malnutrition
Nutrition Disorders
Micronutrients
Trace Elements
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014