Small for Gestational Age at DeliveryPhase 4MISAME-3NCT03533712
Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.
A Phase 4 study testing Fortified balanced energy-protein (BEP) supplement and Fe and folic acid supplement in people with Small for Gestational Age at Delivery and Low Birth Weight, run by University Ghent at 1 site in Burkina Faso.
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. Read more about this study
- Who is it for?
- Ages 15 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Small for Gestational Age at Delivery, Low Birth Weight, Prematurity
- What is being tested?
- Fortified balanced energy-protein (BEP) supplement and Fe and folic acid supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,788 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 30 Oct 2019to 15 Mar 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Being tested
- Fortified balanced energy-protein (BEP) supplement, Fe and folic acid supplement
- Medical subject headings
- Premature Birth, Infant Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortified balanced energy-protein (BEP) supplementDietary 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 supplementDietary supplement
Routine iron and folic acid supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Fortified BEP supplement | Experimental | Intervention: Dietary Supplement: Fortified balanced energy-protein (BEP) supplement + iron and folic acid supplement. Receives: Dietary Supplement: Fortified balanced energy-protein (BEP) supplement |
| Fe and folic acid | Active comparator | Dietary Supplement: Fe and folic acid supplement. Receives: Dietary Supplement: Fe and folic acid supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 72h after birth
Length-for-age Z-scores (LAZ)
Mean of Length-for-Age Z-scores (LAZ), WHO multi-country reference.
Measured: at 6 months (and 12 months on a subsample)
Secondary outcomes (37)
Birth weight
Measured: within 72h after birth
Birth length
Measured: within 72h after birth
Chest circumference
Measured: within 72h after birth
Head circumference
Measured: within 72h after birth
Mid-upper arm circumference
Measured: within 72h after birth
Gestational age
Measured: at delivery
Preterm birth
Incidence of preterm birth at <37 weeks of gestation
Measured: at delivery
Large-for-gestational age
Defined as a birth weight ≥90th centile intergrowth 21st reference
Measured: within 72h after birth
Ponderal or Rohrer's index'
Defined as birth weight/birth length3
Measured: within 72 hours after birth
Fetal loss
Fetal death at <24 completed weeks of gestational age
Measured: during pregnancy
Stillbirths
Fetal death at ≥ 24 weeks gestational age
Measured: during pregnancy
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
Measured: between birth and ≤ 28 days of life
Prenatal weight gain
Weight change between study inclusion until just before delivery: total and trimester specific
Measured: between study inclusion until just before delivery
Gestational weight change
Difference in maternal weight between maternal weight one month after delivery and maternal weight at study inclusion
Measured: between study inclusion until 1 month after delivery
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 .
Measured: (1) at 2 months of child age; (2) at 6 months of child age
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.
Measured: from study inclusion until delivery
Maternal anemia
Hemoglobin concentration <11g/dL
Measured: at the third antenatal consultation
Weight-for-Age Z-score
WAZ, calculated using the WHO growth reference
Measured: at 6 months of age
Weight-for-Length Z-score
WLZ, calculated using the WHO growth reference
Measured: at 6 months of age
Stunting
Length-for-Age Z-score (LAZ) <-2, calculated using the WHO growth reference
Measured: at 6 months of age
Wasting
Weight-for-Length Z-score (WLZ) <-2, calculated using the WHO growth reference
Measured: at 6 months of age
Underweight
Weight-for-Age Z-score (WAZ) <-2, calculated using the WHO growth reference
Measured: at 6 months of age
Incidence of child wasting
Measured: over first 6 months of life
Child weight gain
Monthly change in child weight
Measured: over first 6 months of life
Monthly change in LAZ
Measured: over first 6 months of life
Monthly change in WHZ
Measured: over first 6 months of life
Monthly change in WAZ
Measured: over first 6 months of life
Monthly change in head circumference
Measured: over first 6 months of life
Exclusive breastfeeding
Duration of exclusive breastfeeding
Measured: during the first 6 months of life
Child mortality
Measured: between birth and 6 months of age
Child morbidity symptoms
Signs include fever, vomiting, diarrhea, cough, difficult breathing, running nose
Measured: over first 6 months of life
Child anemia
Hemoglobin concentration <11g/dL
Measured: at 6 months of age
Hemoglobin concentration
Measured: at 6 months of age
Infant body composition
Sub-sample
Measured: first 3 months of life
Maternal body composition
Sub-sample
Measured: first 3 months after delivery
Breast milk composition
Sub-sample
Measured: between 1-2 and 3-4 months
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.
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start30 Oct 2019
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Small for Gestational Age at DeliveryStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The intervention study is a randomized controlled 2x2 factorial efficacy trial. At study inclusion, eligible pregnant women will be randomly assigned to the prenatal intervention or control group, and randomly assigned to a postnatal intervention or control group. The intervention group will receive daily a fortified BEP supplement to be consumed under supervision for the duration of pregnancy/lactation. Both control and intervention group will receive the standard iron and folic acid tablet through the regular ante natal care program.
- Masking
- None (open label)
- Enrolment
- 1,788 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), Institut de Recherche en Sciences de la Sante, Burkina Faso, AfricSanté, Burkina Faso, International Food Policy Research Institute, University of California, Davis, Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, VakgroepLevensmiddelentechnologieVoedselveiligheidGezondheid, University Ghent
- Investigators
- Patrick Kolsteren, Prof. dr., Study chair, University GhentCarl Lachat, Prof. dr., Study director, University GhentKatrien W Vanslambrouck, MD, Principal investigator, University GhentBrenda PH de Kok, MSc., Principal investigator, University GhentLieven F Huybregts, PhD, Principal investigator, IFPRILaeticia Celine Toe, MD MSc., Principal investigator, IRSSSheila Isanaka, Asst. Prof., Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533712
- Sponsor's protocol ID
- OPP1175213
- Acronym
- MISAME-3
- Status last verified
- Mar 2022
- First submitted
- 23 Apr 2018
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share study data with a similar study ongoing in Nepal.
Publications
Argaw A, Toe LC, Hanley-Cook G, Dailey-Chwalibog T, de Kok B, Ouedraogo L, Compaore A, Ouedraogo M, Sawadogo A, Ganaba R, Vanslambrouck K, Kolsteren P, Lachat C, Huybregts L. Effect of prenatal micronutrient-fortified balanced energy-protein supplementation on maternal and newborn body composition: A sub-study from the MISAME-III randomized controlled efficacy trial in rural Burkina Faso. PLoS Med. 2023 Jul 24;20(7):e1004242. doi: 10.1371/journal.pmed.1004242. eCollection 2023 Jul.
PubMed 37486952Argaw A, de Kok B, Toe LC, Hanley-Cook G, Dailey-Chwalibog T, Ouedraogo M, Compaore A, Vanslambrouck K, Ganaba R, Kolsteren P, Lachat C, Huybregts L. Fortified balanced energy-protein supplementation during pregnancy and lactation and infant growth in rural Burkina Faso: A 2 x 2 factorial individually randomized controlled trial. PLoS Med. 2023 Feb 6;20(2):e1004186. doi: 10.1371/journal.pmed.1004186. eCollection 2023 Feb.
PubMed 36745684Hanley-Cook G, Toe LC, Tesfamariam K, de Kok B, Argaw A, Compaore A, Ouedraogo M, Dailey-Chwalibog T, Kolsteren P, Lachat C, Huybregts L. Fortified Balanced Energy-Protein Supplementation, Maternal Anemia, and Gestational Weight Gain: A Randomized Controlled Efficacy Trial among Pregnant Women in Rural Burkina Faso. J Nutr. 2022 Oct 6;152(10):2277-2286. doi: 10.1093/jn/nxac171.
PubMed 35906874de Kok B, Toe LC, Hanley-Cook G, Argaw A, Ouedraogo M, Compaore A, Vanslambrouck K, Dailey-Chwalibog T, Ganaba R, Kolsteren P, Huybregts L, Lachat C. Prenatal fortified balanced energy-protein supplementation and birth outcomes in rural Burkina Faso: A randomized controlled efficacy trial. PLoS Med. 2022 May 13;19(5):e1004002. doi: 10.1371/journal.pmed.1004002. eCollection 2022 May.
PubMed 35560315Hanley-Cook GT, Argaw A, de Kok B, Toe LC, Dailey-Chwalibog T, Ouedraogo M, Kolsteren P, Huybregts L, Lachat C. Seasonality and Day-to-Day Variability of Dietary Diversity: Longitudinal Study of Pregnant Women Enrolled in a Randomized Controlled Efficacy Trial in Rural Burkina Faso. J Nutr. 2022 Sep 6;152(9):2145-2154. doi: 10.1093/jn/nxac104.
PubMed 35524695de Kok B, Argaw A, Hanley-Cook G, Toe LC, Ouedraogo M, Dailey-Chwalibog T, Diop L, Becquey E, Kolsteren P, Lachat C, Huybregts L. Fortified Balanced Energy-Protein Supplements Increase Nutrient Adequacy without Displacing Food Intake in Pregnant Women in Rural Burkina Faso. J Nutr. 2021 Dec 3;151(12):3831-3840. doi: 10.1093/jn/nxab289.
PubMed 34494113Vanslambrouck K, de Kok B, Toe LC, De Cock N, Ouedraogo M, Dailey-Chwalibog T, Hanley-Cook G, Ganaba R, Lachat C, Huybregts L, Kolsteren P. Effect of balanced energy-protein supplementation during pregnancy and lactation on birth outcomes and infant growth in rural Burkina Faso: study protocol for a randomised controlled trial. BMJ Open. 2021 Mar 24;11(3):e038393. doi: 10.1136/bmjopen-2020-038393.
PubMed 33762226
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Fortified Balanced Energy-Protein Supplement on Birth Outcome and Child Growth in Houndé District, Burkina Faso.
- ClinicalTrials.gov ID
- NCT03533712
- Acronym / sponsor ID
- MISAME-3 / OPP1175213
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,788 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), Institut de Recherche en Sciences de la Sante, Burkina Faso, AfricSanté, Burkina Faso, International Food Policy Research Institute, University of California, Davis, Bill and Melinda Gates Foundation
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention study is a randomized controlled 2x2 factorial efficacy trial. At study inclusion, eligible pregnant women will be randomly assigned to the prenatal intervention or control group, and randomly assigned to a postnatal intervention or control group. The intervention group will receive daily a fortified BEP supplement to be consumed under supervision for the duration of pregnancy/lactation. Both control and intervention group will receive the standard iron and folic acid tablet through the regular ante natal care program.
| Arm | Type | Receives |
|---|---|---|
| Fortified BEP supplement | Experimental | Dietary Supplement: Fortified balanced energy-protein (BEP) supplementIntervention: Dietary Supplement: Fortified balanced energy-protein (BEP) supplement + iron and folic acid supplement. |
| Fe and folic acid | Active comparator | Dietary Supplement: Fe and folic acid supplementDietary Supplement: Fe and folic acid supplement. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fortified balanced energy-protein (BEP) supplementThe 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. | Dietary supplement | Fortified BEP supplement |
| Fe and folic acid supplementRoutine iron and folic acid supplementation. | Dietary supplement | Fe and folic acid |
Primary outcome
Small-for-Gestational-age (SGA)
Time frame: within 72h after birth
Incidence of Small-for-Gestational-age (SGA) defined as <10th centile of birthweight for gestational age standard, InterGrowth 21st reference.
Length-for-age Z-scores (LAZ)
Time frame: at 6 months (and 12 months on a subsample)
Mean of Length-for-Age Z-scores (LAZ), WHO multi-country reference.
37 secondary outcomes
Birth weight
Time frame: within 72h after birth
Birth length
Time frame: within 72h after birth
Chest circumference
Time frame: within 72h after birth
Head circumference
Time frame: within 72h after birth
Mid-upper arm circumference
Time frame: within 72h after birth
Gestational age
Time frame: at delivery
Preterm birth
Time frame: at delivery
Large-for-gestational age
Time frame: within 72h after birth
Ponderal or Rohrer's index'
Time frame: within 72 hours after birth
Fetal loss
Time frame: during pregnancy
Stillbirths
Time frame: during pregnancy
Neonatal mortality
Time frame: between birth and ≤ 28 days of life
Prenatal weight gain
Time frame: between study inclusion until just before delivery
Gestational weight change
Time frame: between study inclusion until 1 month after delivery
Probable and possible maternal postnatal depression
Time frame: (1) at 2 months of child age; (2) at 6 months of child age
Women's minimum and mean dietary diversity score
Time frame: from study inclusion until delivery
Maternal anemia
Time frame: at the third antenatal consultation
Weight-for-Age Z-score
Time frame: at 6 months of age
Weight-for-Length Z-score
Time frame: at 6 months of age
Stunting
Time frame: at 6 months of age
Wasting
Time frame: at 6 months of age
Underweight
Time frame: at 6 months of age
Incidence of child wasting
Time frame: over first 6 months of life
Child weight gain
Time frame: over first 6 months of life
Monthly change in LAZ
Time frame: over first 6 months of life
Monthly change in WHZ
Time frame: over first 6 months of life
Monthly change in WAZ
Time frame: over first 6 months of life
Monthly change in head circumference
Time frame: over first 6 months of life
Exclusive breastfeeding
Time frame: during the first 6 months of life
Child mortality
Time frame: between birth and 6 months of age
Child morbidity symptoms
Time frame: over first 6 months of life
Child anemia
Time frame: at 6 months of age
Hemoglobin concentration
Time frame: at 6 months of age
Infant body composition
Time frame: first 3 months of life
Maternal body composition
Time frame: first 3 months after delivery
Breast milk composition
Time frame: between 1-2 and 3-4 months
Relative average telomere length
Time frame: At birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Derived from this study: PubMed 37486952Argaw A, Toe LC, Hanley-Cook G, Dailey-Chwalibog T, de Kok B, Ouedraogo L, Compaore A, Ouedraogo M, Sawadogo A, Ganaba R, Vanslambrouck K, Kolsteren P, Lachat C, Huybregts L. Effect of prenatal micronutrient-fortified balanced energy-protein supplementation on maternal and newborn body composition: A sub-study from the MISAME-III randomized controlled efficacy trial in rural Burkina Faso. PLoS Med. 2023 Jul 24;20(7):e1004242. doi: 10.1371/journal.pmed.1004242. eCollection 2023 Jul.
- Derived from this study: PubMed 36745684Argaw A, de Kok B, Toe LC, Hanley-Cook G, Dailey-Chwalibog T, Ouedraogo M, Compaore A, Vanslambrouck K, Ganaba R, Kolsteren P, Lachat C, Huybregts L. Fortified balanced energy-protein supplementation during pregnancy and lactation and infant growth in rural Burkina Faso: A 2 x 2 factorial individually randomized controlled trial. PLoS Med. 2023 Feb 6;20(2):e1004186. doi: 10.1371/journal.pmed.1004186. eCollection 2023 Feb.
- Derived from this study: PubMed 35906874Hanley-Cook G, Toe LC, Tesfamariam K, de Kok B, Argaw A, Compaore A, Ouedraogo M, Dailey-Chwalibog T, Kolsteren P, Lachat C, Huybregts L. Fortified Balanced Energy-Protein Supplementation, Maternal Anemia, and Gestational Weight Gain: A Randomized Controlled Efficacy Trial among Pregnant Women in Rural Burkina Faso. J Nutr. 2022 Oct 6;152(10):2277-2286. doi: 10.1093/jn/nxac171.
- Derived from this study: PubMed 35560315de Kok B, Toe LC, Hanley-Cook G, Argaw A, Ouedraogo M, Compaore A, Vanslambrouck K, Dailey-Chwalibog T, Ganaba R, Kolsteren P, Huybregts L, Lachat C. Prenatal fortified balanced energy-protein supplementation and birth outcomes in rural Burkina Faso: A randomized controlled efficacy trial. PLoS Med. 2022 May 13;19(5):e1004002. doi: 10.1371/journal.pmed.1004002. eCollection 2022 May.
- Derived from this study: PubMed 35524695Hanley-Cook GT, Argaw A, de Kok B, Toe LC, Dailey-Chwalibog T, Ouedraogo M, Kolsteren P, Huybregts L, Lachat C. Seasonality and Day-to-Day Variability of Dietary Diversity: Longitudinal Study of Pregnant Women Enrolled in a Randomized Controlled Efficacy Trial in Rural Burkina Faso. J Nutr. 2022 Sep 6;152(9):2145-2154. doi: 10.1093/jn/nxac104.
- Derived from this study: PubMed 34494113de Kok B, Argaw A, Hanley-Cook G, Toe LC, Ouedraogo M, Dailey-Chwalibog T, Diop L, Becquey E, Kolsteren P, Lachat C, Huybregts L. Fortified Balanced Energy-Protein Supplements Increase Nutrient Adequacy without Displacing Food Intake in Pregnant Women in Rural Burkina Faso. J Nutr. 2021 Dec 3;151(12):3831-3840. doi: 10.1093/jn/nxab289.
- Derived from this study: PubMed 33762226Vanslambrouck K, de Kok B, Toe LC, De Cock N, Ouedraogo M, Dailey-Chwalibog T, Hanley-Cook G, Ganaba R, Lachat C, Huybregts L, Kolsteren P. Effect of balanced energy-protein supplementation during pregnancy and lactation on birth outcomes and infant growth in rural Burkina Faso: study protocol for a randomised controlled trial. BMJ Open. 2021 Mar 24;11(3):e038393. doi: 10.1136/bmjopen-2020-038393.
- Individual participant dataSharing planned: Yes. Share study data with a similar study ongoing in Nepal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Kolsteren, Prof. dr. study chair
University Ghent
Carl Lachat, Prof. dr. study director
University Ghent
Katrien W Vanslambrouck, MD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fortified balanced energy-protein (BEP) supplement and Fe and folic acid supplement in people with Small for Gestational Age at Delivery and Low Birth Weight, run by University Ghent at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Small-for-Gestational-age (SGA) (time frame: within 72h after birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03533712, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.