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Supplementing Maternal and Infant Diet With High-energy, Micronutrient Fortified Lipid-based Nutrient Supplements (LNS) (iLiNS-DYAD-M)

Primary Purpose

Infant Malnutrition, Malnutrition in Pregnancy

Status
Active
Phase
Phase 3
Locations
Malawi
Study Type
Interventional
Intervention
IFA
MMN
LNS
Sponsored by
Tampere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infant Malnutrition focused on measuring Stunting, Growth failure, Malnutrition, Lipid based nutrient supplement, LNS, Prevention, Malawi, Sub-Saharan Africa, Dietary supplementation, Efficacy, Pregnancy, Infancy, Newborn, Child neurocognitive development, Cardiometabolic health, Lung function

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Ultrasound confirmed pregnancy of no more than 20 completed gestation weeks
  • Permanent resident of Mangochi District Hospital, Malindi Hospital or Lungwena Health Centre catchment areas
  • Availability during the period of the study
  • Signed informed consent

Exclusion Criteria:

  • Less than 15 years of age
  • Need for frequent medical attention due to a chronic health condition
  • Diagnosed asthma treated with regular medication
  • Severe illness warranting hospital referral
  • History of allergy towards peanuts
  • History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
  • Pregnancy complications evident at enrolment visit (moderate to severe oedema, blood Hb concentration < 5 g / dl, systolic blood pressure (BP) > 160 mmHg or diastolic BP > 100 mmHg)
  • Earlier participation in the iLiNS-DYAD-M trial
  • Concurrent participation in any other clinical trial

Sites / Locations

  • University of Malawi, College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

IFA group

MMN group

LNS group

Arm Description

Women during pregnancy: 1 tablet of iron+ folate daily until delivery (60 mg iron + 400 ug folic acid) Women during lactation (from delivery to 6 months post-partum): 1 daily tablet of calcium (200 mg), akin to placebo Children from 6 to 18 months of age: None

Women during pregnancy: 1 tablet of multiple micronutrients daily until delivery Women during lactation (from delivery to 6 months post-partum): 1 daily tablet of multiple micronutrients' Children from 6 to 18 months of age: None

Women during pregnancy: 1 sachet of LNS-P&L (20 g of LNS) daily until delivery Women during lactation (from delivery to 6 months post-partum): 1 daily sachet of LNS-P&L (20 g of LNS) Children from 6 to 18 months of age: 2 daily sachet of LNS-20gM (20 g of LNS)

Outcomes

Primary Outcome Measures

Birth weight
Newborn length
Length for age Z-score (LAZ) at 18 months of age

Secondary Outcome Measures

Anthropometric status (weight, BMI, mid upper arm circumference and triceps and sub-scapular skin-fold thickness)
Gestational age at delivery, proportion of preterm deliveries
Proportion of low birth weight babies
Anaemia and iron status (Hb, ZPP, transferrin receptor), other micronutrient status (vitamin A, B-vitamins, zinc), malarial antigen
Red blood cell essential fatty acid status
Urinary iodine
Total plasma cholesterol concentration
Basal salivary cortisol concentration
Blood pressure
Breast milk composition (essential fatty acids, vitamin A, B-vitamins)
Depressive symptoms (which may be related to essential fatty acid status)
Incidence of febrile malaria episodes
Peripheral blood malaria parasitaemia
Placental malaria histology
Evidence of defined bacteria in the chorionic membranes at delivery (quantitative DNA amplification method)
Prevalence of Neisseria gonorrhoea, Chlamydia trachomatis, in swab samples taken from maternal uterine cervix(qualitative DNA amplification method)
Prevalence of bacterial vaginosis, Trichomonas vaginalis, or candidiasis, in swab samples taken from maternal vagina(direct microscopy)
Malaria immunity
Anthropometric infant status (weight, length, head circumference and mid upper arm circumference)
Infant anaemia and iron status (Hb, ZPP), micronutrient (vitamin A, B-vitamins) and essential fatty acids status, evidence of acute inflammation (CRP, AGP), and malarial antigen and microscopy
Incidence of neonatal hospitalizations
Clinical morbidity
Child feeding practices and maternal report of child sleep patterns
Antibody response to measles vaccination
Malaria immunity
Basal salivary cortisol concentration
Cortisol response to acute stress
Achievement of five motor milestones and four other developmental milestones
Neurobehavioral development
Incidence of serious adverse events
Prevalence of maternal periodontitis
Maternal cognition
Measured with several different tests
Mother - child interaction
Measured with a number of observational tests and questionnaires
The composition of intestinal microbiota
Done with 16s sequencing, from stored stool samples
diastolic blood pressure
Mobil-o-Graph blood pressure monitoring system
central blood pressure
Mobil-o-Graph blood pressure monitoring system
pulse rate
Mobil-o-Graph blood pressure monitoring system
vascular resistance
Mobil-o-Graph blood pressure monitoring system
plasma concentration of glucose
Cobas c702 machine
plasma concentration of cholesterol
Cobas c702 machine
plasma concentration of HDL/LDL cholesterol
Cobas c702 machine
plasma concentration of triglycerides
Cobas c702 machine
plasma concentration of c-reactive protein
Cobas c702 machine
plasma concentration of alkaline phosphatase
Cobas c702 machine
plasma concentration of aspartyl alanine transferase
Cobas c702 machine
plasma concentration of potassium
Cobas c702 machine
plasma concentration of sodium
Cobas c702 machine
plasma concentration of urate
Cobas c702 machine
Spirometry measures functional volume of the lungs
Global Lung Function Initiative standards, Medikro pro spirometry
asthma symptoms
ISAAC questionnaire
allergy symptoms
ISAAC questionnaire
neural functioning
EEG
processing speed
EEG
oculomotor reaction time
eye-tracking
academic achievement
Early Grade Mathematics Assessment, EGMA
height
sitting height
weight
head circumference
mid-upper arm circumference
body composition
Tanita MC-780 MAS

Full Information

First Posted
November 10, 2010
Last Updated
November 18, 2022
Sponsor
Tampere University
Collaborators
Kamuzu University of Health Sciences, University of California, Davis, Bill and Melinda Gates Foundation, Finnish Institute for Health and Welfare, University of Oulu, Finland
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1. Study Identification

Unique Protocol Identification Number
NCT01239693
Brief Title
Supplementing Maternal and Infant Diet With High-energy, Micronutrient Fortified Lipid-based Nutrient Supplements (LNS)
Acronym
iLiNS-DYAD-M
Official Title
A Research Plan for a Randomised, Single-blind, Parallel Group Controlled Trial in Rural Malawi, Testing the Health Effects of Supplementing Maternal Diet During Pregnancy and Lactation and Infant Diet From 6 to 18 Months of Age With High-energy, Micronutrient Fortified Lipid-based Nutrient Supplements (LNS)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University
Collaborators
Kamuzu University of Health Sciences, University of California, Davis, Bill and Melinda Gates Foundation, Finnish Institute for Health and Welfare, University of Oulu, Finland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. Modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. Such modified products have proven acceptable to pregnant women in Malawi and Ghana. In the present trial, the investigators aim to test the effect of LNS on pregnancy and child outcomes, when given during pregnant and lactating women and their infants from 6 to 18 months of age. In control groups, participants will receive either iron+folate tables during pregnancy only or multiple micronutrient tablets during pregnancy and first six months of lactations. The main hypothesis to be tested suggests that the mean length-for-age Z-score (LAZ) of 18-month-old infants who received LNS between 6 and 18 months of age and whose mothers were provided with LNS during pregnancy and the first 6 months of lactation is higher than the mean LAZ score of same age infants who received no dietary supplements and whose mothers received iron-folate supplementation during pregnancy only. To detect the long-term effect of the LNS supplementation, we now propose to conduct a follow-up study when the children are 9 years old, to see if the intervention had effect on children's growth, cardiometabolic and respiratory status and neurocognitive development.
Detailed Description
Pregnant women will be identified from the antenatal clinics of 4 governmental and 2 other health centres. A total of 1400 women meeting set criteria will be randomised into receiving one of the following interventions: 1) Iron and folic acid supplementation to the mother during pregnancy only (IFA group), 2). Multiple micronutrient supplementation to the mother during pregnancy and six months thereafter (MMN group), 3) Lipid-based nutrient supplements to the mother during pregnancy and six months thereafter and to the child from 6 to 18 months of age (LNS group). The mothers will receive LNS or the multiple micronutrients at 2-weekly intervals at their homes during pregnancy and weekly during first six months of lactation. Children in the LNS group will receive LNS weekly, starting at 6 months. Mothers will be medically examined and tested for defined laboratory parameters at enrolment, at 36 gestation weeks, at birth or soon thereafter, and at 6 months after delivery. Child size will be assessed at birth or soon thereafter and at 3, 6, 12, and 18 months of age. The mothers will undergo a morbidity evaluation fortnightly and the children weekly. 864 mother-infant pairs will undergo the complete intervention and follow-up, as described above. The remaining 536 participants will undergo a simplified intervention and follow-up, in which there are no interventions after birth and the child follow-up consists only of 4 3 health centre and one home visits; first at 1 week, then at six weeks (at home) and at 6 and 18 months of age. A sub-study on the the development of intestinal microbiome was added in August 2011. This entails the collection of stool samples from the mother at 1 month after delivery, breast milk samples from the mothers at 1, 3, and 6 months after delivery and stool and urine samples from the children repeated during the a8 months of intervention. The aim of this subproject is to study the development of the infants' intestinal microbiota, its predictors and its association to child growth and other health outcomes. At the same time point, the sample size was reduced from 2400 to 1400 participants (due to constraints in funding). A one year post-intervention follow-up for participants in the complete follow-up was added to the study protocol in August 2013. The intervention will be stopped when the participants are 18 months old. Thereafter, there will be an anthropometrirc assessment and blood and urine draw at the study clinic at 24 and 30 months of age. Stool samples will be collected from the participants at the age of 21, 24, 27 and 30 months, to study the development of intestinal microbiome. In a follow-up study, when the children are 10 years old, we will assess: child growth using standard anthropometric measures, cardiometabolic health by measuring body composition, blood pressure and plasma lipids, neurodevelopment by measuring neural function, cognitive skills and education attainment using EE and EGMA and Raven's questionnaires, lung function with spirometry and allergy symptoms and asthma using ISAAC questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Malnutrition, Malnutrition in Pregnancy
Keywords
Stunting, Growth failure, Malnutrition, Lipid based nutrient supplement, LNS, Prevention, Malawi, Sub-Saharan Africa, Dietary supplementation, Efficacy, Pregnancy, Infancy, Newborn, Child neurocognitive development, Cardiometabolic health, Lung function

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1391 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IFA group
Arm Type
Active Comparator
Arm Description
Women during pregnancy: 1 tablet of iron+ folate daily until delivery (60 mg iron + 400 ug folic acid) Women during lactation (from delivery to 6 months post-partum): 1 daily tablet of calcium (200 mg), akin to placebo Children from 6 to 18 months of age: None
Arm Title
MMN group
Arm Type
Active Comparator
Arm Description
Women during pregnancy: 1 tablet of multiple micronutrients daily until delivery Women during lactation (from delivery to 6 months post-partum): 1 daily tablet of multiple micronutrients' Children from 6 to 18 months of age: None
Arm Title
LNS group
Arm Type
Experimental
Arm Description
Women during pregnancy: 1 sachet of LNS-P&L (20 g of LNS) daily until delivery Women during lactation (from delivery to 6 months post-partum): 1 daily sachet of LNS-P&L (20 g of LNS) Children from 6 to 18 months of age: 2 daily sachet of LNS-20gM (20 g of LNS)
Intervention Type
Dietary Supplement
Intervention Name(s)
IFA
Intervention Description
Women during pregnancy: 1 tablet of iron+ folate daily until delivery (60 mg iron + 400 ug folic acid) Women during lactation (from delivery to 6 months post-partum): 1 daily tablet of calcium (200 mg), akin to placebo Children from 6 to 18 months of age: None
Intervention Type
Dietary Supplement
Intervention Name(s)
MMN
Intervention Description
Women during pregnancy: 1 tablet of multiple micronutrients daily until delivery Women during lactation (from delivery to 6 months post-partum): 1 daily tablet of multiple micronutrients Children from 6 to 18 months of age: None
Intervention Type
Dietary Supplement
Intervention Name(s)
LNS
Intervention Description
Women during pregnancy: 1 sachet of LNS-P&L (20 g of LNS) daily until delivery Women during lactation (from delivery to 6 months post-partum): 1 daily sachet of LNS-P&L (20 g of LNS) Children from 6 to 18 months of age: 2 daily sachet of LNS-20gM (20 g of LNS)
Primary Outcome Measure Information:
Title
Birth weight
Time Frame
approx 20 weeks after enrollment (within 48 hours)
Title
Newborn length
Time Frame
At 1 week of age
Title
Length for age Z-score (LAZ) at 18 months of age
Time Frame
12 months after enrollment (age 18 months)
Secondary Outcome Measure Information:
Title
Anthropometric status (weight, BMI, mid upper arm circumference and triceps and sub-scapular skin-fold thickness)
Time Frame
at ~ 36 wk gestation and 6 months postpartum
Title
Gestational age at delivery, proportion of preterm deliveries
Time Frame
At delivery
Title
Proportion of low birth weight babies
Time Frame
At birth
Title
Anaemia and iron status (Hb, ZPP, transferrin receptor), other micronutrient status (vitamin A, B-vitamins, zinc), malarial antigen
Time Frame
At ~ 36 wk gestation and 6 mo postpartum
Title
Red blood cell essential fatty acid status
Time Frame
At ~ 36 wk gestation
Title
Urinary iodine
Time Frame
At ~ 36 wk gestation
Title
Total plasma cholesterol concentration
Time Frame
At ~ 36 wk gestation
Title
Basal salivary cortisol concentration
Time Frame
At ~ 28 and ~ 36 wk gestation
Title
Blood pressure
Time Frame
At 36 wk gestation
Title
Breast milk composition (essential fatty acids, vitamin A, B-vitamins)
Time Frame
At 6 mo postpartum
Title
Depressive symptoms (which may be related to essential fatty acid status)
Time Frame
At 4 weeks and at 6 months postpartum
Title
Incidence of febrile malaria episodes
Time Frame
During pregnancy
Title
Peripheral blood malaria parasitaemia
Time Frame
At 32 wk gestation and at delivery
Title
Placental malaria histology
Time Frame
At delivery
Title
Evidence of defined bacteria in the chorionic membranes at delivery (quantitative DNA amplification method)
Time Frame
At birth
Title
Prevalence of Neisseria gonorrhoea, Chlamydia trachomatis, in swab samples taken from maternal uterine cervix(qualitative DNA amplification method)
Time Frame
At one week after delivery
Title
Prevalence of bacterial vaginosis, Trichomonas vaginalis, or candidiasis, in swab samples taken from maternal vagina(direct microscopy)
Time Frame
At one week after delivery
Title
Malaria immunity
Time Frame
At enrolment, at ~ 36 wk gestation, and 6 months post-partum
Title
Anthropometric infant status (weight, length, head circumference and mid upper arm circumference)
Time Frame
At 7 days of age and at 6, 12 and 18 months of age. After the intervention at 24 and 30 months and at 10 y of age.
Title
Infant anaemia and iron status (Hb, ZPP), micronutrient (vitamin A, B-vitamins) and essential fatty acids status, evidence of acute inflammation (CRP, AGP), and malarial antigen and microscopy
Time Frame
At 6 and 18 months of age
Title
Incidence of neonatal hospitalizations
Time Frame
At or before age 28 days
Title
Clinical morbidity
Time Frame
Between 0 and 18 months of age
Title
Child feeding practices and maternal report of child sleep patterns
Time Frame
At 6, 12 and 18 months of age
Title
Antibody response to measles vaccination
Time Frame
At 18 months of age
Title
Malaria immunity
Time Frame
At 6 and 18 months of age
Title
Basal salivary cortisol concentration
Time Frame
At 6, 12 and 18 months of age
Title
Cortisol response to acute stress
Time Frame
At 6 and 18 months of age
Title
Achievement of five motor milestones and four other developmental milestones
Time Frame
From 0 to 18 mo
Title
Neurobehavioral development
Time Frame
At 18 months of age
Title
Incidence of serious adverse events
Time Frame
During pregnancy and 18 months of infant follow-up
Title
Prevalence of maternal periodontitis
Time Frame
At one week after delivery
Title
Maternal cognition
Description
Measured with several different tests
Time Frame
6 months after delivery
Title
Mother - child interaction
Description
Measured with a number of observational tests and questionnaires
Time Frame
6 months after delivery
Title
The composition of intestinal microbiota
Description
Done with 16s sequencing, from stored stool samples
Time Frame
1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months of child age
Title
diastolic blood pressure
Description
Mobil-o-Graph blood pressure monitoring system
Time Frame
Child is 10 years
Title
central blood pressure
Description
Mobil-o-Graph blood pressure monitoring system
Time Frame
Child is 10 years
Title
pulse rate
Description
Mobil-o-Graph blood pressure monitoring system
Time Frame
Child is 10 years
Title
vascular resistance
Description
Mobil-o-Graph blood pressure monitoring system
Time Frame
Child is 10 years
Title
plasma concentration of glucose
Description
Cobas c702 machine
Time Frame
Child is 10 years
Title
plasma concentration of cholesterol
Description
Cobas c702 machine
Time Frame
Child is 10 years
Title
plasma concentration of HDL/LDL cholesterol
Description
Cobas c702 machine
Time Frame
Child is 10 years
Title
plasma concentration of triglycerides
Description
Cobas c702 machine
Time Frame
Child is 10 years
Title
plasma concentration of c-reactive protein
Description
Cobas c702 machine
Time Frame
Child is 10 years
Title
plasma concentration of alkaline phosphatase
Description
Cobas c702 machine
Time Frame
Child is 10 years
Title
plasma concentration of aspartyl alanine transferase
Description
Cobas c702 machine
Time Frame
Child is 10 years
Title
plasma concentration of potassium
Description
Cobas c702 machine
Time Frame
Child is 10 years
Title
plasma concentration of sodium
Description
Cobas c702 machine
Time Frame
Child is 10 years
Title
plasma concentration of urate
Description
Cobas c702 machine
Time Frame
Child is 10 years
Title
Spirometry measures functional volume of the lungs
Description
Global Lung Function Initiative standards, Medikro pro spirometry
Time Frame
Child is 10 years
Title
asthma symptoms
Description
ISAAC questionnaire
Time Frame
Child is 10 years
Title
allergy symptoms
Description
ISAAC questionnaire
Time Frame
Child is 10 years
Title
neural functioning
Description
EEG
Time Frame
Child is 10 years
Title
processing speed
Description
EEG
Time Frame
Child is 10 years
Title
oculomotor reaction time
Description
eye-tracking
Time Frame
Child is 10 years
Title
academic achievement
Description
Early Grade Mathematics Assessment, EGMA
Time Frame
Child is 10 years
Title
height
Time Frame
Child is 10 years
Title
sitting height
Time Frame
Child is 10 years
Title
weight
Time Frame
Child is 10 years
Title
head circumference
Time Frame
Child is 10 years
Title
mid-upper arm circumference
Time Frame
Child is 10 years
Title
body composition
Description
Tanita MC-780 MAS
Time Frame
Child is 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ultrasound confirmed pregnancy of no more than 20 completed gestation weeks Permanent resident of Mangochi District Hospital, Malindi Hospital or Lungwena Health Centre catchment areas Availability during the period of the study Signed informed consent Exclusion Criteria: Less than 15 years of age Need for frequent medical attention due to a chronic health condition Diagnosed asthma treated with regular medication Severe illness warranting hospital referral History of allergy towards peanuts History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care Pregnancy complications evident at enrolment visit (moderate to severe oedema, blood Hb concentration < 5 g / dl, systolic blood pressure (BP) > 160 mmHg or diastolic BP > 100 mmHg) Earlier participation in the iLiNS-DYAD-M trial Concurrent participation in any other clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Ashorn, MD, PhD
Organizational Affiliation
University of Tampere Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Malawi, College of Medicine
City
Mangochi
Country
Malawi

12. IPD Sharing Statement

Citations:
PubMed Identifier
36078607
Citation
Liu Z, Fan YM, Ashorn P, Chingwanda C, Maleta K, Hallamaa L, Hyoty H, Chaima D, Ashorn U. Lack of Associations between Environmental Exposures and Environmental Enteric Dysfunction among 18-Month-Old Children in Rural Malawi. Int J Environ Res Public Health. 2022 Sep 1;19(17):10891. doi: 10.3390/ijerph191710891.
Results Reference
derived
PubMed Identifier
35909334
Citation
Salenius M, Pyykko J, Ashorn U, Dewey KG, Gondwe A, Harjunmaa U, Maleta K, Nkhoma M, Vosti SA, Ashorn P, Adubra L. Association between prenatal provision of lipid-based nutrient supplements and caesarean delivery: Findings from a randomised controlled trial in Malawi. Matern Child Nutr. 2022 Oct;18(4):e13414. doi: 10.1111/mcn.13414. Epub 2022 Jul 31.
Results Reference
derived
PubMed Identifier
35317414
Citation
Haskell MJ, Maleta K, Arnold CD, Jorgensen JM, Fan YM, Ashorn U, Matchado A, Monangi NK, Zhang G, Xu H, Belling E, Landero J, Chappell J, Muglia LJ, Hallman M, Ashorn P, Dewey KG. Provision of Small-Quantity Lipid-Based Nutrient Supplements Increases Plasma Selenium Concentration in Pregnant Women in Malawi: A Secondary Outcome of a Randomized Controlled Trial. Curr Dev Nutr. 2022 Mar 7;6(3):nzac013. doi: 10.1093/cdn/nzac013. eCollection 2022 Mar.
Results Reference
derived
PubMed Identifier
35155983
Citation
Smith JW, Matchado AJ, Wu LS, Arnold CD, Burke SM, Maleta KM, Ashorn P, Stewart CP, Shaikh S, Ali H, Labrique AB, West KP Jr, Christian P, Dewey KG, Groopman JD, Schulze KJ. Longitudinal Assessment of Prenatal, Perinatal, and Early-Life Aflatoxin B1 Exposure in 828 Mother-Child Dyads from Bangladesh and Malawi. Curr Dev Nutr. 2022 Jan 7;6(2):nzab153. doi: 10.1093/cdn/nzab153. eCollection 2022 Feb.
Results Reference
derived
PubMed Identifier
35149871
Citation
Kortekangas E, Fan YM, Chaima D, Lehto KM, Malamba-Banda C, Matchado A, Chingwanda C, Liu Z, Ashorn U, Cheung YB, Dewey KG, Maleta K, Ashorn P. Associations between Gut Microbiota and Intestinal Inflammation, Permeability and Damage in Young Malawian Children. J Trop Pediatr. 2022 Feb 3;68(2):fmac012. doi: 10.1093/tropej/fmac012. Erratum In: J Trop Pediatr. 2022 Aug 4;68(5):
Results Reference
derived
PubMed Identifier
34543432
Citation
Adu-Afarwuah S, Arnold CD, Lartey A, Okronipa H, Maleta K, Ashorn P, Ashorn U, Fan YM, Matchado A, Kortekangas E, Oaks BM, Jackson KH, Dewey KG. Small-Quantity Lipid-Based Nutrient Supplements Increase Infants' Plasma Essential Fatty Acid Levels in Ghana and Malawi: A Secondary Outcome Analysis of the iLiNS-DYAD Randomized Trials. J Nutr. 2022 Jan 11;152(1):286-301. doi: 10.1093/jn/nxab329.
Results Reference
derived
PubMed Identifier
34084993
Citation
Jorgensen JM, Young R, Ashorn P, Ashorn U, Chaima D, Davis JCC, Goonatilleke E, Kumwenda C, Lebrilla CB, Maleta K, Sadalaki J, Totten SM, Wu LD, Zivkovic AM, Dewey KG. Associations of Human Milk Oligosaccharides and Bioactive Proteins with Infant Morbidity and Inflammation in Malawian Mother-Infant Dyads. Curr Dev Nutr. 2021 Apr 29;5(5):nzab072. doi: 10.1093/cdn/nzab072. eCollection 2021 May.
Results Reference
derived
PubMed Identifier
33096556
Citation
Jorgensen JM, Young R, Ashorn P, Ashorn U, Chaima D, Davis JCC, Goonatilleke E, Kumwenda C, Lebrilla CB, Maleta K, Prado EL, Sadalaki J, Totten SM, Wu LD, Zivkovic AM, Dewey KG. Associations of human milk oligosaccharides and bioactive proteins with infant growth and development among Malawian mother-infant dyads. Am J Clin Nutr. 2021 Jan 4;113(1):209-220. doi: 10.1093/ajcn/nqaa272.
Results Reference
derived
PubMed Identifier
33054890
Citation
Adu-Afarwuah S, Arnold CD, Maleta K, Ashorn P, Ashorn U, Jorgensen JM, Fan YM, Nkhoma M, Bendabenda J, Matchado A, Dewey KG. Consumption of multiple micronutrients or small-quantity lipid-based nutrient supplements containing iodine at the recommended dose during pregnancy, compared with iron and folic acid, does not affect women's urinary iodine concentration in rural Malawi: a secondary outcome analysis of the iLiNS DYAD trial. Public Health Nutr. 2021 Jul;24(10):3049-3057. doi: 10.1017/S1368980020003250. Epub 2020 Oct 15.
Results Reference
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PubMed Identifier
31909811
Citation
Kamng'ona AW, Young R, Arnold CD, Patson N, Jorgensen JM, Kortekangas E, Chaima D, Malamba C, Ashorn U, Cheung YB, Ashorn P, Maleta K, Dewey KG. Provision of Lipid-Based Nutrient Supplements to Mothers During Pregnancy and 6 Months Postpartum and to Their Infants from 6 to 18 Months Promotes Infant Gut Microbiota Diversity at 18 Months of Age but Not Microbiota Maturation in a Rural Malawian Setting: Secondary Outcomes of a Randomized Trial. J Nutr. 2020 Apr 1;150(4):918-928. doi: 10.1093/jn/nxz298.
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PubMed Identifier
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Citation
Kortekangas E, Young R, Cheung YB, Fan YM, Jorgensen JM, Kamng'ona AW, Chaima D, Ashorn U, Dewey KG, Maleta K, Ashorn P. A Prospective Study on Child Morbidity and Gut Microbiota in Rural Malawi. J Pediatr Gastroenterol Nutr. 2019 Oct;69(4):431-437. doi: 10.1097/MPG.0000000000002435.
Results Reference
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PubMed Identifier
31010435
Citation
Bendabenda J, Patson N, Hallamaa L, Ashorn U, Dewey KG, Ashorn P, Maleta K. Does anthropometric status at 6 months predict the over-dispersion of malaria infections in children aged 6-18 months? A prospective cohort study. Malar J. 2019 Apr 22;18(1):143. doi: 10.1186/s12936-019-2778-y.
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PubMed Identifier
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Barua P, Beeson JG, Maleta K, Ashorn P, Rogerson SJ. The impact of early life exposure to Plasmodium falciparum on the development of naturally acquired immunity to malaria in young Malawian children. Malar J. 2019 Jan 18;18(1):11. doi: 10.1186/s12936-019-2647-8.
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PubMed Identifier
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Citation
Oaks BM, Jorgensen JM, Baldiviez LM, Adu-Afarwuah S, Maleta K, Okronipa H, Sadalaki J, Lartey A, Ashorn P, Ashorn U, Vosti S, Allen LH, Dewey KG. Prenatal Iron Deficiency and Replete Iron Status Are Associated with Adverse Birth Outcomes, but Associations Differ in Ghana and Malawi. J Nutr. 2019 Mar 1;149(3):513-521. doi: 10.1093/jn/nxy278.
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25646337
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Links:
URL
http://www.medcol.mw/
Description
College of Medicine homepage
URL
http://www.ncbi.nlm.nih.gov/pubmed/25646337
Description
Publication on the primary birth outcome results
URL
http://www.ncbi.nlm.nih.gov/pubmed/25926413
Description
Publication on the primary child growth outcome results

Learn more about this trial

Supplementing Maternal and Infant Diet With High-energy, Micronutrient Fortified Lipid-based Nutrient Supplements (LNS)

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