Overview

This trial is active, not recruiting.

Conditions maternal malnutrition, growth failure, mortality, morbidity, stunting
Treatment comprehensive maternal nutrition intervention
Sponsor University of Colorado, Denver
Collaborator Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date August 2013
End date October 2019
Trial size 7374 participants
Trial identifier NCT01883193, 12-1672, OPP1055867, U10HD076474-01

Summary

Multi-country three-arm, individually randomized, non-masked, controlled trial to ascertain the benefits of ensuring optimal maternal nutrition before conception and providing an evidence base for programmatic priority directed to minimizing the risk of malnutrition in all females of reproductive age.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Arm 1 will commence the comprehensive maternal nutrition intervention at 3-7 months postpartum. Delivery of the intervention will be monitored biweekly by collection of empty and unused sachets of the lipid-based supplement (LNS), maternal report, and casual observation of household behavior. Arm 1 participants will be weighed monthly and Body Mass Index (BMI) calculated. If BMI <20 an additional energy supplement will be provided. Menstrual history will be obtained at each visit and a urine pregnancy test will be performed if menses is delayed.
comprehensive maternal nutrition intervention multi micronutrient (MMN) fortified lipid-based supplement
The nutrition intervention will be delivered before conception or at 12 weeks gestation and continued through delivery and compared with a control group. The supplement to be used is a multi-micronutrient (MMN) fortified lipid-based supplement composed of dried skimmed milk, soybean and peanut extract, sugar, maltodextrin stabilizers, and emulsifiers.
(Experimental)
Participants in Arm 2 will commence the same comprehensive maternal nutrition intervention at 12 weeks gestation.
comprehensive maternal nutrition intervention multi micronutrient (MMN) fortified lipid-based supplement
The nutrition intervention will be delivered before conception or at 12 weeks gestation and continued through delivery and compared with a control group. The supplement to be used is a multi-micronutrient (MMN) fortified lipid-based supplement composed of dried skimmed milk, soybean and peanut extract, sugar, maltodextrin stabilizers, and emulsifiers.
(No Intervention)
Participants in Arm 3 will receive biweekly visits to monitor pregnancy status. No health advice will be given other than information about prenatal care, location of delivery, and breastfeeding education in the third trimester.

Primary Outcomes

Measure
Neonatal linear growth
time frame: <24 hours of age

Secondary Outcomes

Measure
Length-for-age Z-scores
time frame: age 0.5, 1, 3, 6, 12, 18 and 24 months postnatal
Estimate fetal growth
time frame: 12 weeks gestation
Mean birth weight
time frame: at birth
Incidence of low birth weight (LBW) infants
time frame: at birth
Perinatal Mortality
time frame: From 20 weeks gestation through 1 month of age
Incidence of severe neonatal and infant infectious disease
time frame: birth to 6 months of age
Epigenome (Maternal)
time frame: baseline, 12 and 34 weeks gestation, delivery, and 3 months postpartum (maternal); 2 weeks and 3 months of age (infant)
Epigenome (Infant)
time frame: 2 weeks and 3 months of age
Deep phenotyping of maternal metabolic and nutritional status
time frame: 12 and 34 weeks gestation, delivery, and 3 months postpartum
Microbiome (maternal)
time frame: 12 & 34 weeks gestation and delivery (maternal)
Microbiome (infant)
time frame: 14 days and 3 months of age (infant)
Composition of breast milk
time frame: 14 days postpartum

Eligibility Criteria

Female participants from 16 years up to 35 years old.

Inclusion Criteria: - 16-35 years of age; - expectation to have first or further pregnancy without intent to utilize contraception - Hb >8 g/dL Exclusion Criteria: - Nulliparous women who do not agree to hospital delivery (equipped for caesarian section) or/and do not have ready access to such a facility.

Additional Information

Official title Women First: Preconception Maternal Nutrition
Principal investigator Nancy Krebs, MD,MS
Description The objective is to determine the benefits to the offspring of women in poor, food-insecure environments of commencing a daily comprehensive maternal nutrition supplement (with additional balanced calorie/protein supplement for underweight participants) ≥ 3 months prior to conception versus the benefits of commencing the same supplement at 12 weeks gestation and also to compare offspring outcomes with those of a control group which receives no supplement.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.