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

March 24, 2025 updated by: Per Ashorn, Tampere University

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. child growth using standard anthropometric measures,
  2. cardiometabolic health by measuring body composition, blood pressure and plasma lipids,
  3. neurodevelopment by measuring neural function, cognitive skills and education attainment using EE and EGMA and Raven's questionnaires,
  4. lung function with spirometry and allergy symptoms and asthma using ISAAC questionnaire.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1391

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
      • Mangochi, Malawi
        • University of Malawi, College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: IFA group
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
Dietary supplement: IFA
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
Active Comparator: MMN group
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
Dietary supplement: MMN
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
Experimental: LNS group
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)
Dietary supplement: LNS
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Birth weight
Time Frame: approx 20 weeks after enrollment (within 48 hours)
approx 20 weeks after enrollment (within 48 hours)
Newborn length
Time Frame: At 1 week of age
At 1 week of age
Length for age Z-score (LAZ) at 18 months of age
Time Frame: 12 months after enrollment (age 18 months)
12 months after enrollment (age 18 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
at ~ 36 wk gestation and 6 months postpartum
Gestational age at delivery, proportion of preterm deliveries
Time Frame: At delivery
At delivery
Proportion of low birth weight babies
Time Frame: At birth
At birth
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
At ~ 36 wk gestation and 6 mo postpartum
Red blood cell essential fatty acid status
Time Frame: At ~ 36 wk gestation
At ~ 36 wk gestation
Urinary iodine
Time Frame: At ~ 36 wk gestation
At ~ 36 wk gestation
Total plasma cholesterol concentration
Time Frame: At ~ 36 wk gestation
At ~ 36 wk gestation
Basal salivary cortisol concentration
Time Frame: At ~ 28 and ~ 36 wk gestation
At ~ 28 and ~ 36 wk gestation
Blood pressure
Time Frame: At 36 wk gestation
At 36 wk gestation
Breast milk composition (essential fatty acids, vitamin A, B-vitamins)
Time Frame: At 6 mo postpartum
At 6 mo postpartum
Depressive symptoms (which may be related to essential fatty acid status)
Time Frame: At 4 weeks and at 6 months postpartum
At 4 weeks and at 6 months postpartum
Incidence of febrile malaria episodes
Time Frame: During pregnancy
During pregnancy
Peripheral blood malaria parasitaemia
Time Frame: At 32 wk gestation and at delivery
At 32 wk gestation and at delivery
Placental malaria histology
Time Frame: At delivery
At delivery
Evidence of defined bacteria in the chorionic membranes at delivery (quantitative DNA amplification method)
Time Frame: At birth
At birth
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
At one week after delivery
Prevalence of bacterial vaginosis, Trichomonas vaginalis, or candidiasis, in swab samples taken from maternal vagina(direct microscopy)
Time Frame: At one week after delivery
At one week after delivery
Malaria immunity
Time Frame: At enrolment, at ~ 36 wk gestation, and 6 months post-partum
At enrolment, at ~ 36 wk gestation, and 6 months post-partum
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.
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.
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
At 6 and 18 months of age
Incidence of neonatal hospitalizations
Time Frame: At or before age 28 days
At or before age 28 days
Clinical morbidity
Time Frame: Between 0 and 18 months of age
Between 0 and 18 months of age
Child feeding practices and maternal report of child sleep patterns
Time Frame: At 6, 12 and 18 months of age
At 6, 12 and 18 months of age
Antibody response to measles vaccination
Time Frame: At 18 months of age
At 18 months of age
Malaria immunity
Time Frame: At 6 and 18 months of age
At 6 and 18 months of age
Basal salivary cortisol concentration
Time Frame: At 6, 12 and 18 months of age
At 6, 12 and 18 months of age
Cortisol response to acute stress
Time Frame: At 6 and 18 months of age
At 6 and 18 months of age
Achievement of five motor milestones and four other developmental milestones
Time Frame: From 0 to 18 mo
From 0 to 18 mo
Neurobehavioral development
Time Frame: At 18 months of age
At 18 months of age
Incidence of serious adverse events
Time Frame: During pregnancy and 18 months of infant follow-up
During pregnancy and 18 months of infant follow-up
Prevalence of maternal periodontitis
Time Frame: At one week after delivery
At one week after delivery
Maternal cognition
Time Frame: 6 months after delivery
Measured with several different tests
6 months after delivery
Mother - child interaction
Time Frame: 6 months after delivery
Measured with a number of observational tests and questionnaires
6 months after delivery
The composition of intestinal microbiota
Time Frame: 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months of child age
Done with 16s sequencing, from stored stool samples
1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months of child age
diastolic blood pressure
Time Frame: Child is 10 years
Mobil-o-Graph blood pressure monitoring system
Child is 10 years
central blood pressure
Time Frame: Child is 10 years
Mobil-o-Graph blood pressure monitoring system
Child is 10 years
pulse rate
Time Frame: Child is 10 years
Mobil-o-Graph blood pressure monitoring system
Child is 10 years
vascular resistance
Time Frame: Child is 10 years
Mobil-o-Graph blood pressure monitoring system
Child is 10 years
plasma concentration of glucose
Time Frame: Child is 10 years
Cobas c702 machine
Child is 10 years
plasma concentration of cholesterol
Time Frame: Child is 10 years
Cobas c702 machine
Child is 10 years
plasma concentration of HDL/LDL cholesterol
Time Frame: Child is 10 years
Cobas c702 machine
Child is 10 years
plasma concentration of triglycerides
Time Frame: Child is 10 years
Cobas c702 machine
Child is 10 years
plasma concentration of c-reactive protein
Time Frame: Child is 10 years
Cobas c702 machine
Child is 10 years
plasma concentration of alkaline phosphatase
Time Frame: Child is 10 years
Cobas c702 machine
Child is 10 years
plasma concentration of aspartyl alanine transferase
Time Frame: Child is 10 years
Cobas c702 machine
Child is 10 years
plasma concentration of potassium
Time Frame: Child is 10 years
Cobas c702 machine
Child is 10 years
plasma concentration of sodium
Time Frame: Child is 10 years
Cobas c702 machine
Child is 10 years
plasma concentration of urate
Time Frame: Child is 10 years
Cobas c702 machine
Child is 10 years
Spirometry measures functional volume of the lungs
Time Frame: Child is 10 years
Global Lung Function Initiative standards, Medikro pro spirometry
Child is 10 years
asthma symptoms
Time Frame: Child is 10 years
ISAAC questionnaire
Child is 10 years
allergy symptoms
Time Frame: Child is 10 years
ISAAC questionnaire
Child is 10 years
neural functioning
Time Frame: Child is 10 years
EEG
Child is 10 years
processing speed
Time Frame: Child is 10 years
EEG
Child is 10 years
oculomotor reaction time
Time Frame: Child is 10 years
eye-tracking
Child is 10 years
academic achievement
Time Frame: Child is 10 years
Early Grade Mathematics Assessment, EGMA
Child is 10 years
height
Time Frame: Child is 10 years
Child is 10 years
sitting height
Time Frame: Child is 10 years
Child is 10 years
weight
Time Frame: Child is 10 years
Child is 10 years
head circumference
Time Frame: Child is 10 years
Child is 10 years
mid-upper arm circumference
Time Frame: Child is 10 years
Child is 10 years
body composition
Time Frame: Child is 10 years
Tanita MC-780 MAS
Child is 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tampere University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, Davis
Bill and Melinda Gates Foundation
Kamuzu University of Health Sciences
University of Oulu
Finnish Institute for Health and Welfare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Per Ashorn, MD, PhD, University of Tampere Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2010

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 11, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • iLiNS-DYAD-M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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