Clinical trial NCT01239693: Supplementing Maternal and Infant Diet With High-energy, Micronutrient Fortified Lipid-based Nutrient Supplements (LNS)
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: 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
Lead sponsor: Tampere University
Sponsor class: OTHER
Collaborators: name: Kamuzu University of Health Sciences
name: University of California, Davis
name: Bill and Melinda Gates Foundation
name: Finnish Institute for Health and Welfare
name: University of Oulu
First posted: 2010-11-11
Enrollment: 1391
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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.

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

Primary outcomes:
measure: Birth weight
timeFrame: approx 20 weeks after enrollment (within 48 hours)
measure: Newborn length
timeFrame: At 1 week of age
measure: Length for age Z-score (LAZ) at 18 months of age
timeFrame: 12 months after enrollment (age 18 months)
Secondary outcomes:
measure: Anthropometric status (weight, BMI, mid upper arm circumference and triceps and sub-scapular skin-fold thickness)
timeFrame: at ~ 36 wk gestation and 6 months postpartum
measure: Gestational age at delivery, proportion of preterm deliveries
timeFrame: At delivery
measure: Proportion of low birth weight babies
timeFrame: At birth
measure: Anaemia and iron status (Hb, ZPP, transferrin receptor), other micronutrient status (vitamin A, B-vitamins, zinc), malarial antigen
timeFrame: At ~ 36 wk gestation and 6 mo postpartum
measure: Red blood cell essential fatty acid status
timeFrame: At ~ 36 wk gestation
measure: Urinary iodine
timeFrame: At ~ 36 wk gestation
measure: Total plasma cholesterol concentration
timeFrame: At ~ 36 wk gestation
measure: Basal salivary cortisol concentration
timeFrame: At ~ 28 and ~ 36 wk gestation
measure: Blood pressure
timeFrame: At 36 wk gestation
measure: Breast milk composition (essential fatty acids, vitamin A, B-vitamins)
timeFrame: At 6 mo postpartum
measure: Depressive symptoms (which may be related to essential fatty acid status)
timeFrame: At 4 weeks and at 6 months postpartum
measure: Incidence of febrile malaria episodes
timeFrame: During pregnancy
measure: Peripheral blood malaria parasitaemia
timeFrame: At 32 wk gestation and at delivery
measure: Placental malaria histology
timeFrame: At delivery
measure: Evidence of defined bacteria in the chorionic membranes at delivery (quantitative DNA amplification method)
timeFrame: At birth
measure: Prevalence of Neisseria gonorrhoea, Chlamydia trachomatis, in swab samples taken from maternal uterine cervix(qualitative DNA amplification method)
timeFrame: At one week after delivery
measure: Prevalence of bacterial vaginosis, Trichomonas vaginalis, or candidiasis, in swab samples taken from maternal vagina(direct microscopy)
timeFrame: At one week after delivery
measure: Malaria immunity
timeFrame: At enrolment, at ~ 36 wk gestation, and 6 months post-partum
measure: Anthropometric infant status (weight, length, head circumference and mid upper arm circumference)
timeFrame: 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.
measure: 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
timeFrame: At 6 and 18 months of age
measure: Incidence of neonatal hospitalizations
timeFrame: At or before age 28 days
measure: Clinical morbidity
timeFrame: Between 0 and 18 months of age
measure: Child feeding practices and maternal report of child sleep patterns
timeFrame: At 6, 12 and 18 months of age
measure: Antibody response to measles vaccination
timeFrame: At 18 months of age
measure: Malaria immunity
timeFrame: At 6 and 18 months of age
measure: Basal salivary cortisol concentration
timeFrame: At 6, 12 and 18 months of age
measure: Cortisol response to acute stress
timeFrame: At 6 and 18 months of age
measure: Achievement of five motor milestones and four other developmental milestones
timeFrame: From 0 to 18 mo
measure: Neurobehavioral development
timeFrame: At 18 months of age
measure: Incidence of serious adverse events
timeFrame: During pregnancy and 18 months of infant follow-up
measure: Prevalence of maternal periodontitis
timeFrame: At one week after delivery
measure: Maternal cognition
timeFrame: 6 months after delivery
measure: Mother - child interaction
timeFrame: 6 months after delivery
measure: The composition of intestinal microbiota
timeFrame: 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months of child age
measure: diastolic blood pressure
timeFrame: Child is 10 years
measure: central blood pressure
timeFrame: Child is 10 years
measure: pulse rate
timeFrame: Child is 10 years
measure: vascular resistance
timeFrame: Child is 10 years
measure: plasma concentration of glucose
timeFrame: Child is 10 years
measure: plasma concentration of cholesterol
timeFrame: Child is 10 years
measure: plasma concentration of HDL/LDL cholesterol
timeFrame: Child is 10 years
measure: plasma concentration of triglycerides
timeFrame: Child is 10 years
measure: plasma concentration of c-reactive protein
timeFrame: Child is 10 years
measure: plasma concentration of alkaline phosphatase
timeFrame: Child is 10 years
measure: plasma concentration of aspartyl alanine transferase
timeFrame: Child is 10 years
measure: plasma concentration of potassium
timeFrame: Child is 10 years
measure: plasma concentration of sodium
timeFrame: Child is 10 years
measure: plasma concentration of urate
timeFrame: Child is 10 years
measure: Spirometry measures functional volume of the lungs
timeFrame: Child is 10 years
measure: asthma symptoms
timeFrame: Child is 10 years
measure: allergy symptoms
timeFrame: Child is 10 years
measure: neural functioning
timeFrame: Child is 10 years
measure: processing speed
timeFrame: Child is 10 years
measure: oculomotor reaction time
timeFrame: Child is 10 years
measure: academic achievement
timeFrame: Child is 10 years
measure: height
timeFrame: Child is 10 years
measure: sitting height
timeFrame: Child is 10 years
measure: weight
timeFrame: Child is 10 years
measure: head circumference
timeFrame: Child is 10 years
measure: mid-upper arm circumference
timeFrame: Child is 10 years
measure: body composition
timeFrame: Child is 10 years
Other outcomes:
Locations:
city: Mangochi
country: Malawi
facility: University of Malawi, College of Medicine
Study officials:
affiliation: University of Tampere Medical School
name: Per Ashorn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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