Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.

Prematurity Clinical Trial

— MISAME-3  

Official title:

Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03533712
• Other study ID #: OPP1175213
• Status: Completed
• Phase: Phase 4
• Start date: October 30, 2019
• Est. completion date: March 15, 2022

Study information

• Verified date: March 2022
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The 2016 WHO antenatal care guidelines stated that pregnant women in undernourished populations should receive fortified balanced energy-protein (BEP) supplements to reduce the risk of stillbirth and small-for-gestational-age birth. However, acceptable supplements and delivery channels must be determined for different contexts.

The present proposal therefore will 1) perform a formative study to identify the most suitable (acceptability and utilization) BEP supplement for pregnant women in rural Burkina Faso (phase 1) and 2) evaluate the efficacy of this supplement to improve birth weight, fetal and infant growth (phase 2). The nutritional composition of the BEP supplement was established during an expert convening at the BMGF in September 2016. Private sector partners will prepare the supplements in the selected forms with the recommended nutrient composition.

Description:

Pregnancy remains a challenging period in the life of many women in low- and middle-income countries. Maternal mortality remains high and many newborns suffer from premature delivery and /or gestational growth retardation both in length and in weight accumulation.

The 2016 WHO antenatal care guidelines stated that pregnant women in undernourished populations should receive fortified balanced energy-protein (BEP) supplements to reduce the risk of stillbirth and small-for-gestational-age birth. However, acceptable supplements and delivery channels must be determined for different contexts.

The purpose of this study is to assess the efficacy of a fortified BEP supplement for pregnant and lactating women to improve birth weight, fetal and infant growth.

This research includes 2 phases:

• Phase 1 - part 1: Formative research to identify preferred product types of a fortified BEP supplement;

• Phase 1 - part 2: Formative research with a 10-week home-feeding trial to determine the acceptability of a fortified BEP supplement for longer-term consumption.

• Phase 2: A community-based, individually randomized efficacy trial of the fortified BEP food supplement including 1,776 pregnant and lactating women aimed at testing 2 hypothesis: supplementing pregnant and lactating women with a fortified BEP supplement will improve fetal growth; improving fetal growth will have a positive effect on health and growth during infancy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1788
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 40 Years

Eligibility

Inclusion Criteria:

• Participant age (15-40 years).

• Pregnant as determined by a pregnancy test and confirmed by ultrasound.

• Women who signed the informed consent form (in case of minors the parents or husband signs)

Exclusion Criteria:

• Women planning to leave the area before delivery.

• Women who plan to deliver outside the area.

• Pregnancies with a gestational age > 20 weeks at study inclusion.

• Women with multi-fetal gestation (exclusion from analysis).

• Women who are allergic to peanuts.

Related Conditions & MeSH terms

• Birth Weight
• Infant Malnutrition
• Infant Nutrition Disorders
• Low Birth Weight
• Malnutrition
• Prematurity
• Small for Gestational Age at Delivery

Intervention

Dietary Supplement:
• Fortified balanced energy-protein (BEP) supplement
The product contains the following target nutrients: Total energy: 250-500 kcal per daily serving Fat content: 10-60% of energy intake Protein content: 16 g (range 14-18 g) with a Digestible Indispensable Amino Acid Score (DIAAS) of = 0.9 Carbohydrate (CHO) Content: no specific recommendations, relative to fat and protein content. Trans Fats: <1% energy intake Micronutrients include the following: A, D, E, K, B1 (thiamin), B2 (riboflavin), B3 (niacin), B6 (pyridoxine), B9 (folate), B12 and C; minerals: iron, zinc, iodine, calcium, phosphorous, copper, and selenium. The final composition of macro en micronutrients will be available after the acceptability testing (phase 1) and will be determined by 1) the product type and 2) the preferred taste.
• Fe and folic acid supplement
Routine iron and folic acid supplementation.

Locations

Country	Name	City	State
Burkina Faso	Houndé district	Houndé	Tuy

Sponsors (7)

Lead Sponsor	Collaborator
University Ghent	AfricSanté, Burkina Faso, Bill and Melinda Gates Foundation, Harvard School of Public Health (HSPH), Institut de Recherche en Sciences de la Sante, Burkina Faso, International Food Policy Research Institute, University of California, Davis

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Small-for-Gestational-age (SGA)	Incidence of Small-for-Gestational-age (SGA) defined as <10th centile of birthweight for gestational age standard, InterGrowth 21st reference.	within 72h after birth
Primary	Length-for-age Z-scores (LAZ)	Mean of Length-for-Age Z-scores (LAZ), WHO multi-country reference.	at 6 months (and 12 months on a subsample)
Secondary	Birth weight		within 72h after birth
Secondary	Birth length		within 72h after birth
Secondary	Chest circumference		within 72h after birth
Secondary	Head circumference		within 72h after birth
Secondary	Mid-upper arm circumference		within 72h after birth
Secondary	Gestational age		at delivery
Secondary	Preterm birth	Incidence of preterm birth at <37 weeks of gestation	at delivery
Secondary	Large-for-gestational age	Defined as a birth weight =90th centile intergrowth 21st reference	within 72h after birth
Secondary	Ponderal or Rohrer's index'	Defined as birth weight/birth length3	within 72 hours after birth
Secondary	Fetal loss	Fetal death at <24 completed weeks of gestational age	during pregnancy
Secondary	Stillbirths	Fetal death at = 24 weeks gestational age	during pregnancy
Secondary	Neonatal mortality	(1) Early neonatal mortality: deaths between birth and = 7 days of life; (2) Neonatal mortality: deaths between birth and =28 days of life; (3) Late neonatal mortality deaths between >7 days and =28 days of life	between birth and = 28 days of life
Secondary	Prenatal weight gain	Weight change between study inclusion until just before delivery: total and trimester specific	between study inclusion until just before delivery
Secondary	Gestational weight change	Difference in maternal weight between maternal weight one month after delivery and maternal weight at study inclusion	between study inclusion until 1 month after delivery
Secondary	Probable and possible maternal postnatal depression	Measured using the 10-item Edinburgh postnatal depression scale. Probable depression is defined as EPDS>12. Possible depression is defined as EPDS>9 .	(1) at 2 months of child age; (2) at 6 months of child age
Secondary	Women's minimum and mean dietary diversity score	Measured biweekly using the 10 food group indicator as proposed by FAO. Minimum dietary diversity is defined as having consumed at least 5 food groups over the last 24 hours.	from study inclusion until delivery
Secondary	Maternal anemia	Hemoglobin concentration <11g/dL	at the third antenatal consultation
Secondary	Weight-for-Age Z-score	WAZ, calculated using the WHO growth reference	at 6 months of age
Secondary	Weight-for-Length Z-score	WLZ, calculated using the WHO growth reference	at 6 months of age
Secondary	Stunting	Length-for-Age Z-score (LAZ) <-2, calculated using the WHO growth reference	at 6 months of age
Secondary	Wasting	Weight-for-Length Z-score (WLZ) <-2, calculated using the WHO growth reference	at 6 months of age
Secondary	Underweight	Weight-for-Age Z-score (WAZ) <-2, calculated using the WHO growth reference	at 6 months of age
Secondary	Incidence of child wasting		over first 6 months of life
Secondary	Child weight gain	Monthly change in child weight	over first 6 months of life
Secondary	Monthly change in LAZ		over first 6 months of life
Secondary	Monthly change in WHZ		over first 6 months of life
Secondary	Monthly change in WAZ		over first 6 months of life
Secondary	Monthly change in head circumference		over first 6 months of life
Secondary	Exclusive breastfeeding	Duration of exclusive breastfeeding	during the first 6 months of life
Secondary	Child mortality		between birth and 6 months of age
Secondary	Child morbidity symptoms	Signs include fever, vomiting, diarrhea, cough, difficult breathing, running nose	over first 6 months of life
Secondary	Child anemia	Hemoglobin concentration <11g/dL	at 6 months of age
Secondary	Hemoglobin concentration		at 6 months of age
Secondary	Infant body composition	Sub-sample	first 3 months of life
Secondary	Maternal body composition	Sub-sample	first 3 months after delivery
Secondary	Breast milk composition	Sub-sample	between 1-2 and 3-4 months
Secondary	Relative average telomere length	The umbilical cord blood will be analyzed to verify telomere length using qPCR on a sub-sample. Telomere lengths will be expressed as the ratio of telomere copy number to single-copy gene number (T/S) relative to the mean T/S ratio of the entire sample.	At birth