Effect of Prenatal Nutritional Supplementation on Birth Outcome in Hounde District, Burkina Faso

NCT00909974 | Completed Phase 4 DMC

• 1 other identifier: ZEIN2004PR298
• Study Type: interventional
• Target: 1,302
• Locations: 1 country
• Sites: 1

Brief Summary

Low birth weight (LBW; birth weight\<2,500g) is the most important determinant of mortality and morbidity in the neonatal period. It is also a very important factor in predicting nutritional status, health and development in childhood. It even influences health in adult life, contributing to the vicious cycle of disease and poverty. The high rate LBW in DCs represents therefore a major public health problem. Maternal chronic energy deficiency is assumed to be a major determinant of the problem in these countries along with prenatal micronutrient deficiencies. A large body of recent evidence points out that multiple micronutrient supplementation as such has only a modest beneficial effect on fetal growth. Therefore, it is expected that providing these multiple micronutrients in a food supplement covering energy requirement needs of pregnant women will have an effect of public health importance on children's health. This study has the objective of improving children's health by improving birth outcome and fetal growth through the provision of a food supplement enriched in multimicronutrients during pregnancy. This research includes 2 constituents:

1. 1.a pilot phase during which dietary behavior of pregnant women is assessed as a component for optimal fetal growth
2. 2.a randomized, placebo-controlled trial, including 1300 pregnant women aimed at testing 2 hypotheses: supplementing pregnant women with a food supplement containing a multivitamin-minerals mix will improve fetal growth; improved fetal growth will have a positive effect on health and growth during infancy.

Conditions

Intrauterine Growth Retardation; Low Birth Weight

Keywords

multiple micronutrients; energy deficiency

Outcome Measures

Primary Outcomes (2)

• Weight, length and Rohrer index at birth, and gestational duration in singleton pregnancies.

  At birth

• Mortality, morbidity and growth during the first year of life

  Monthly during infancy

Secondary Outcomes (1)

• Placental weight; LBW; SGA; thoracic circumference; head circumference; mid-upper arm circumference; hemoglobin concentration in mothers and in newborns; soluble sTfR in cord blood as an iron status indicator; preterm birth; stillbirth; perinatal death

  Different depending on mother and child

Study Arms (2)

Food supplement (FS)

EXPERIMENTAL

Recipe of food supplement: 33% peanut butter, 32% soy flour, 15% vegetable oil, 20% sugar, UNIMMAP in powdered form Nutritional composition (per dose of 72g) Energy 1.56 MJ, protein 14.7 g, vitamin A 881 µg, vitamin E 13 mg, vitamin D 5 µg, vitamin B1 1.4 mg, vitamin B2 1.4 mg, niacin 21 mg, vitamin B6 1.9 mg, vitamin B12 2.6 µg, folic acid 461 µg, vitamin C 70 mg, iron 30 mg, zinc 15 mg, copper 2 mg, selenium 65 µg, and iodine 150 µg

Dietary Supplement: Food supplement enriched with multiple micronutrients

UNIMMAP

ACTIVE COMPARATOR

UNIMMAPin tablet form: vitamin A 800µg, vitamin E 10 mg, vitamin D 5 µg, vitamin B1 1.4 mg, vitamin B2 1.4 mg, niacin 18 mg, vitamin B6 1.9 mg, vitamin B12 2.6 µg, folic acid 400 µg, vitamin C 70 mg, iron 30 mg, zinc 15 mg, copper 2 mg, selenium 65 µg, and iodine 150 µg

Dietary Supplement: UNIMMAP - multiple micronutrients

Interventions

UNIMMAP - multiple micronutrients DIETARY_SUPPLEMENT

Daily supplementation of one UNIMMAP tablet multiple micronutrient supplements (MMN): UNIMMAP: vitamin A 800µg, vitamin E 10 mg, vitamin D 5 µg, vitamin B1 1.4 mg, vitamin B2 1.4 mg, niacin 18 mg, vitamin B6 1.9 mg, vitamin B12 2.6 µg, folic acid 400 µg, vitamin C 70 mg, iron 30 mg, zinc 15 mg, copper 2 mg, selenium 65 µg, and iodine 150 µg

UNIMMAP

Food supplement enriched with multiple micronutrients DIETARY_SUPPLEMENT

One dose of 72g per day during whole pregnancy Recipe of food supplement: 33% peanut butter, 32% soy flour, 15% vegetable oil, 20% sugar, UNIMMAP in powdered form Nutritional composition (per dose of 72g) Energy 1.56 MJ, protein 14.7 g, vitamin A 881 µg, vitamin E 13 mg, vitamin D 5 µg, vitamin B1 1.4 mg, vitamin B2 1.4 mg, niacin 21 mg, vitamin B6 1.9 mg, vitamin B12 2.6 µg, folic acid 461 µg, vitamin C 70 mg, iron 30 mg, zinc 15 mg, copper 2 mg, selenium 65 µg, and iodine 150 µg

Also known as: Lipid based nutritional supplement (LNS)

Food supplement (FS)

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All the women of child-bearing age (15-44 years) living in the study area (4 100) will be visited monthly to assess early pregnancy and will be invited to participate in the trial.

You may not qualify if:

• planning to move outside the district within the 2 years following the start of the trial.
• regularly using a contraceptive method.
• already pregnant at the start of the trial.

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• University Ghent: collaborator
• Flemish Interuniversity Council (VLIR): collaborator
• Nutrition Third World, Belgium: collaborator

Study Sites (1)

Centre Muraz, 2054, Avenue Mamadou KONATE

Bobo-Dioulasso, Burkina Faso

Location

Related Publications (5)

• Toe LC, Bouckaert KP, De Beuf K, Roberfroid D, Meda N, Thas O, Van Camp J, Kolsteren PW, Huybregts LF. Seasonality modifies the effect of a lipid-based nutrient supplement for pregnant rural women on birth length. J Nutr. 2015 Mar;145(3):634-9. doi: 10.3945/jn.114.203448. Epub 2015 Jan 14.

  PMID: 25733482 DERIVED

• Lanou H, Huybregts L, Roberfroid D, Nikiema L, Kouanda S, Van Camp J, Kolsteren P. Prenatal nutrient supplementation and postnatal growth in a developing nation: an RCT. Pediatrics. 2014 Apr;133(4):e1001-8. doi: 10.1542/peds.2013-2850. Epub 2014 Mar 3.

  PMID: 24590752 DERIVED

• Huybregts L, Roberfroid D, Lanou H, Meda N, Taes Y, Valea I, D'Alessandro U, Kolsteren P, Van Camp J. Prenatal lipid-based nutrient supplements increase cord leptin concentration in pregnant women from rural Burkina Faso. J Nutr. 2013 May;143(5):576-83. doi: 10.3945/jn.112.171181. Epub 2013 Mar 27.

  PMID: 23535609 DERIVED

• Valea I, Tinto H, Drabo MK, Huybregts L, Sorgho H, Ouedraogo JB, Guiguemde RT, van Geertruyden JP, Kolsteren P, D'Alessandro U; FSP/MISAME study Group. An analysis of timing and frequency of malaria infection during pregnancy in relation to the risk of low birth weight, anaemia and perinatal mortality in Burkina Faso. Malar J. 2012 Mar 16;11:71. doi: 10.1186/1475-2875-11-71.

  PMID: 22433778 DERIVED

• Huybregts L, Roberfroid D, Lanou H, Menten J, Meda N, Van Camp J, Kolsteren P. Prenatal food supplementation fortified with multiple micronutrients increases birth length: a randomized controlled trial in rural Burkina Faso. Am J Clin Nutr. 2009 Dec;90(6):1593-600. doi: 10.3945/ajcn.2009.28253. Epub 2009 Oct 7.

  PMID: 19812173 DERIVED

Related Links

• Institute of Tropical Medicine Prince Leopold, Antwerp, Belgium

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lieven Huybregts, MSc

  University Ghent, Belgium

  PRINCIPAL INVESTIGATOR

• Patrick Kolsteren, PhD

  Institute of Tropical Medicine, Belgium; Ghent University, Belgium

  STUDY CHAIR

• Dominqiue Roberfroid, MD

  Institute of Tropical Medicine, Belgium

  PRINCIPAL INVESTIGATOR

• Nicolas Meda, PhD

  Centre Muraz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 28, 2009
• First Posted: May 29, 2009
• Study Start: February 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 14, 2010

Record last verified: 2010-09

Locations

BU (1)