Prevention of Intrauterine Growth Retardation in Hounde District, Burkina Faso

NCT00642408 | Completed Phase 4 DMC

• 1 other identifier: IUGR
• Study Type: interventional
• Target: 1,370
• Locations: 1 country
• Sites: 1

Brief Summary

Intrauterine Growth Retardation 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 IUGR in DCs represents therefore a major public health problem. Maternal malnutrition is usually assumed to be a major determinant of the problem in these countries. An increasing amount of evidence points to the potential role played by micronutrient deficiencies during pregnancy. The adverse effect on birthweight of maternal iron deficiency anaemia, lack of zinc and lack of iodine have been documented. A similar effect is suspected for Vitamin A, Magnesium, Calcium, Copper,Thiamine, Pyridoxine and Folic acid. It seems that not one specific deficiency alone is responsible for this adverse effect, but rather a combination of them. Therefore, it is expected that covering needs of pregnant women by a multivitamin-mineral supplement will have an effect of public health importance on children's health. This study has the objective of improving children's health by preventing intrauterine growth retardation through the provision of multivitamin-mineral supplements during pregnancy. This research includes 2 constituents:

1. 1.a pilot phase during which socio-anthropological, nutritional and epidemiological aspects of IUGR will be assessed through qualitative and epidemiological methods.
2. 2.a double-blind, randomised, placebo-controlled trial, including 1215 pregnant women aimed at testing 3 hypotheses: supplementing pregnant women with a multivitamin-minerals mix will improve fetal growth; improved fetal growth will have a positive effect on health and growth during infancy; covering nutritional needs of lactating women with a multivitamin-minerals mix during 3 months after delivery will improve health and growth of infants.

Conditions

Multiple Micronutrient Deficiencies During Pregnancy

Outcome Measures

Primary Outcomes (2)

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

  At birth

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

  Monthly during infancy

Secondary Outcomes (1)

• 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)

MMN

EXPERIMENTAL

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

Dietary Supplement: Multiple micronutrient supplements (MMN)

IFA

ACTIVE COMPARATOR

iron and folic acid (IFA)(iron 60 mg and folic acid 400µg).

Dietary Supplement: IFA

Interventions

Multiple micronutrient supplements (MMN) DIETARY_SUPPLEMENT

Iron and folic acid: iron 60 mg and folic acid 400µg

MMN

IFA DIETARY_SUPPLEMENT

Iron and folic acid (IFA)(iron 60 mg and folic acid 400µg).

IFA

Eligibility Criteria

• Age: 15 Years - 44 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:

• Will be excluded from the study women :
• 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
• Nutrition Tiers Monde, Belgique: collaborator
• Centre Muraz: collaborator

Study Sites (1)

Centre Muraz, 2054, Avenue Mamadou KONATE

Bobo-Dioulasso, BP 390, Burkina Faso

Location

Related Publications (5)

• Roberfroid D, Huybregts L, Lanou H, Ouedraogo L, Henry MC, Meda N, Kolsteren P; MISAME study group. Impact of prenatal multiple micronutrients on survival and growth during infancy: a randomized controlled trial. Am J Clin Nutr. 2012 Apr;95(4):916-24. doi: 10.3945/ajcn.111.029033. Epub 2012 Feb 29.

  PMID: 22378724 DERIVED

• Roberfroid D, Huybregts L, Lanou H, Habicht JP, Henry MC, Meda N, Kolsteren P. Prenatal micronutrient supplements cumulatively increase fetal growth. J Nutr. 2012 Mar;142(3):548-54. doi: 10.3945/jn.111.148015. Epub 2012 Feb 1.

  PMID: 22298571 DERIVED

• Roberfroid D, Huybregts L, Habicht JP, Lanou H, Henry MC, Meda N, d'Alessandro U, Kolsteren P; MISAME Study Group. Randomized controlled trial of 2 prenatal iron supplements: is there a dose-response relation with maternal hemoglobin? Am J Clin Nutr. 2011 May;93(5):1012-8. doi: 10.3945/ajcn.110.006239. Epub 2011 Mar 2.

  PMID: 21367950 DERIVED

• Roberfroid D, Huybregts L, Lanou H, Henry MC, Meda N, Kolsteren F P; Micronutriments et Sante de la Mere et de l'Enfant Study (MISAME) Group. Effect of maternal multiple micronutrient supplements on cord blood hormones: a randomized controlled trial. Am J Clin Nutr. 2010 Jun;91(6):1649-58. doi: 10.3945/ajcn.2009.28855. Epub 2010 Apr 7.

  PMID: 20375185 DERIVED

• Roberfroid D, Huybregts L, Lanou H, Henry MC, Meda N, Menten J, Kolsteren P; MISAME Study Group. Effects of maternal multiple micronutrient supplementation on fetal growth: a double-blind randomized controlled trial in rural Burkina Faso. Am J Clin Nutr. 2008 Nov;88(5):1330-40. doi: 10.3945/ajcn.2008.26296.

  PMID: 18996870 DERIVED

Related Links

• Institute of Tropical Medicine Prince Leopold, Antwerp, Belgium

Study Officials

• Dominique Roberfroid, MD

  ITM Antwerp

  PRINCIPAL INVESTIGATOR

• Nicolas Meda, MD

  Head of the Epidemiology Unit in Centre Muraz

  PRINCIPAL INVESTIGATOR

• Patrick Kolsteren, MD

  head of the Nutrition and Child Health Unit in the Institute of Tropical Medicine (ITM, Antwerp, Belgium)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 13, 2008
• First Posted: March 25, 2008
• Study Start: June 1, 2003
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: September 14, 2010

Record last verified: 2010-09

Locations

BU (1)