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Women First: Preconception Maternal Nutrition (WF)

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ClinicalTrials.gov Identifier: NCT01883193
Recruitment Status : Active, not recruiting
First Posted : June 21, 2013
Last Update Posted : October 16, 2018
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Instituto de Nutricion de Centroamerica y Panama (INCAP)
Kinshasa School of Public Health
Jawaharlal Nehru Medical College
Aga Khan University
RTI International
Information provided by (Responsible Party):
University of Colorado, Denver

June 18, 2013
June 21, 2013
October 16, 2018
August 2013
October 2019   (Final data collection date for primary outcome measure)
Neonatal linear growth [ Time Frame: <24 hours of age ]
Research assistants will obtain neonatal length measurement at <24 hours of age.
Neonatal linear growth [ Time Frame: 48 hours of age ]
Research assistants will obtain neonatal length measurement at 2 days of age.
Complete list of historical versions of study NCT01883193 on ClinicalTrials.gov Archive Site
  • Length-for-age Z-scores [ Time Frame: age 0.5, 1, 3, 6, 12, 18 and 24 months postnatal ]
    Research assistants will obtain infant anthropometry measurements, which include length, head circumference, triceps skin folds, Mid Upper Arm Circumference (MUAC), and weight, at age 0.5, 1, 3, 6, 12, 18 and 24 months of age. Length-for-age Z-scores will be compared for offspring of mothers randomized to the three intervention arms.
  • Estimate fetal growth [ Time Frame: 12 weeks gestation ]
    Ultrasound measurements will be undertaken at 12 weeks gestation with the goals of confirming gestational age and estimating fetal growth.
  • Mean birth weight [ Time Frame: at birth ]
    As a dichotomous variable, the cutoff of 2500 g does not have the power of the continuum of birth length, but is included because of the long history of use in determining which newborns are severely underweight and this association with impaired neonatal and long-term prognosis. The design of this study will allow distinction between pre-term birth (PTB) and growth retardation of the term infant (mature IUGR).
  • Incidence of low birth weight (LBW) infants [ Time Frame: at birth ]
    As a dichotomous variable, the cutoff of 2500 g does not have the power of the continuum of birth length, but is included because of the long history of use in determining which newborns are severely underweight and this association with impaired neonatal and long-term prognosis. The design of this study will allow distinction between pre-term birth (PTB) and growth retardation of the term infant (mature IUGR).
  • Perinatal Mortality [ Time Frame: From 20 weeks gestation through 1 month of age ]
    The outcome is to determine, in poor food insecure communities if a daily comprehensive maternal nutrition supplement starting ≥ 3 months preconception and continuing throughout pregnancy will reduce the incidence of offspring perinatal mortality (including still births), compared with that for offspring of mothers who commence the same supplement starting at 12-16 weeks gestation.
  • Incidence of severe neonatal and infant infectious disease [ Time Frame: birth to 6 months of age ]
    Outcome measure is number of acute visits / admissions to health center/hospital for severe infectious disease. This secondary outcome will provide insight into the importance of maternal and fetal nutrition in the early prenatal development of host-defense mechanisms and, through comparison with the prenatal and control Arms, on the importance of maternal nutrition throughout pregnancy. It is further intended to collect minor morbidity data.
  • Epigenome (Maternal) [ Time Frame: baseline, 12 and 34 weeks gestation, delivery, and 3 months postpartum (maternal); 2 weeks and 3 months of age (infant) ]
    To compare longitudinal changes between groups in the maternal epigenome (including blood, buccal swabs, and possibly other readily obtainable samples) at baseline, 12 weeks pregnancy (prior to initiation of LNS in Arm 2), 34 weeks pregnancy, and at 3 months postpartum. Also will collect placental, fetal and cord blood epigenome at delivery by group and infant epigenome at 3 months with fingerstick blood and buccal swabs.
  • Epigenome (Infant) [ Time Frame: 2 weeks and 3 months of age ]
    To compare longitudinal changes between groups in the maternal epigenome (including blood, buccal swabs, and possibly other readily obtainable samples) at baseline, 12 weeks pregnancy (prior to initiation of LNS in Arm 2), 34 weeks pregnancy, and at 3 months postpartum. Also will collect placental, fetal and cord blood epigenome at delivery by group and infant epigenome at 3 months with fingerstick blood and buccal swabs.
  • Deep phenotyping of maternal metabolic and nutritional status [ Time Frame: 12 and 34 weeks gestation, delivery, and 3 months postpartum ]
    The outcome represents deep phenotyping by measuring in maternal tissues: hormones, metabolites, measures of inflammation, oxidant stress and immune function/status, and nutrient biomarkers as possible indices of fundamental metabolic alterations resulting from improved long-term maternal nutrition in food insecure populations. Longitudinal blood samples will be collected from maternal participants in Arms 1 and 2 at baseline, 12 weeks gestation (prior to initiation of LNS in Arm 2), 34 weeks gestation, delivery and 3 months postpartum. Samples will also be collected from participants in Arm 3 at 34 weeks gestation and at 3 months postpartum.
  • Microbiome (maternal) [ Time Frame: 12 & 34 weeks gestation and delivery (maternal) ]
    Based on potential long-term effects on maternal nutritional and metabolic state from preconception intervention, we hypothesize that the gut microbiota will differ between the two intervention arms at the three proposed time points.
  • Microbiome (infant) [ Time Frame: 14 days and 3 months of age (infant) ]
    Based on potential long-term effects on maternal nutritional and metabolic state from preconception intervention, we hypothesize that the gut microbiota will differ between the two intervention arms at the three proposed time points.
  • Composition of breast milk [ Time Frame: 14 days postpartum ]
    We hypothesize that improved maternal nutrition at the time of greatest plasticity in early pregnancy will favorably influence maternal metabolic and nutritional status throughout pregnancy and thus potentially the composition of breast milk in terms of hormonal content, immune factors, cytokines, and gut growth factors.
  • Neurodevelopment assessment [ Time Frame: 24 mo age ]
    Offspring randomized to receive neurodevelopmental evaluation (BSID-III or InterNDA, 2:1 ratio) at 24 mo of age
  • Length-for-age Z-scores [ Time Frame: age 0.5, 1, 3 and 6 months postnatal ]
    Research assistants will obtain infant anthropometry measurements, which include length, head circumference, triceps skin folds, Mid Upper Arm Circumference (MUAC), and weight, at age 0.5, 1, 3, and 6 months of age. Length-for-age Z-scores will be compared for offspring of mothers randomized to the three intervention arms.
  • Estimate longitudinal fetal growth [ Time Frame: 12, 20-22, and 32-34 weeks gestation ]
    Ultrasound measurements will be undertaken at 12, 20-22, and 32-34 weeks gestation with the goals of confirming gestational age and estimating longitudinal fetal growth, the latter from measurements of femur and humeral length.
  • Mean birth weight and incidence of low birth weight (LBW) infants [ Time Frame: at birth ]
    As a dichotomous variable, the cutoff of 2500 g does not have the power of the continuum of birth length, but is included because of the long history of use in determining which newborns are severely underweight and this association with impaired neonatal and long-term prognosis. The design of this study will allow distinction between pre-term birth (PTB) and growth retardation of the term infant (mature IUGR).
  • Perinatal Mortality [ Time Frame: after 20 weeks gestation up to 1 months of age ]
    The outcome is to determine, in poor food insecure communities if a daily comprehensive maternal nutrition supplement starting ≥ 3 months preconception and continuing throughout pregnancy will reduce the incidence of offspring perinatal mortality (including still births), compared with that for offspring of mothers who commence the same supplement starting at 12-16 weeks gestation.
  • Incidence of severe neonatal and infant infectious disease [ Time Frame: birth to 6 months of age ]
    Outcome measure is number of acute visits / admissions to health center/hospital for severe infectious disease. This secondary outcome will provide insight into the importance of maternal and fetal nutrition in the early prenatal development of host-defense mechanisms and, through comparison with the prenatal and control Arms, on the importance of maternal nutrition throughout pregnancy. It is further intended to collect minor morbidity data.
  • Epigenome (Maternal and Infant) [ Time Frame: baseline, 12 weeks and 30 weeks gestation, delivery, and 3 months postpartum (maternal); delivery and 3 months of age (infant) ]
    To compare longitudinal changes between groups in the maternal epigenome (including blood, buccal swabs, and possibly other readily obtainable samples) at baseline, 12 weeks pregnancy (prior to initiation of LNS in Arm 2), 30 weeks pregnancy, and at 3 months postpartum. Also will collect placental, fetal and cord blood epigenome at delivery by group and infant epigenome at 3 months with fingerstick blood.
  • Changes in zinc (Zn) homeostasis [ Time Frame: 12 weeks gestation ]
    These investigations will address in detail group differences in Zn homeostasis reflecting longer-term Zn status (by exchangeable Zn pool (EZP) size) as well as absorption of current intake of bioavailable Zn, including Zn absorption from LNS and (separately) from remainder of diet. Comparisons will be made between Arm 1 and 2 only with 20 maternal participants per arm, per site.
  • Deep phenotyping of maternal metabolic and nutritional status [ Time Frame: 12 and 30 weeks gestation, delivery and at 3 months postpartum (mother) and 14 days of age (infant) ]
    The outcome represents deep phenotyping by measuring in maternal tissues: hormones, metabolites, measures of inflammation, oxidant stress and immune function/status, and nutrient biomarkers as possible indices of fundamental metabolic alterations resulting from improved long-term maternal nutrition in food insecure populations. Longitudinal blood samples will be collected from maternal participants in Arms 1 and 2 at 12 weeks gestation (prior to initiation of LNS in Arm 2), 30 weeks gestation, delivery and 3 months postpartum and from infants at 14 weeks.
  • Microbiome [ Time Frame: 12 & 30 weeks gestation and delivery (<48 hours) and 14 days of age for the infant ]
    Based on potential long-term effects on maternal nutritional and metabolic state from preconception intervention, we hypothesize that the gut microbiota will differ between the two intervention arms at the three proposed time points. Will obtain samples from women in Arm 1 and Arm 2 at each site but will immediately analyze samples from 50 women per arm.
  • Composition of breast milk [ Time Frame: 14 days postpartum ]
    We hypothesize that improved maternal nutrition at the time of greatest plasticity in early pregnancy will favorably influence maternal metabolic and nutritional status throughout pregnancy and thus potentially the composition of breast milk in terms of hormonal content, immune factors, cytokines, and gut growth factors.
Not Provided
Not Provided
 
Women First: Preconception Maternal Nutrition
Women First: Preconception Maternal Nutrition
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Maternal Malnutrition
  • Growth Failure
  • Mortality
  • Morbidity
  • Stunting
Dietary Supplement: Comprehensive Maternal Nutrition Intervention
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.
Other Names:
  • multi micronutrient (MMN) fortified lipid-based supplement
  • lipid-based nutrient supplement
  • LNS
  • Experimental: Arm 1: Preconception
    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.
    Intervention: Dietary Supplement: Comprehensive Maternal Nutrition Intervention
  • Experimental: Arm 2: Pregnancy
    Participants in Arm 2 will commence the same comprehensive maternal nutrition intervention at 12 weeks gestation.
    Intervention: Dietary Supplement: Comprehensive Maternal Nutrition Intervention
  • No Intervention: Arm 3: Control
    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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
7374
5760
October 2019
October 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
16 Years to 35 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Congo, The Democratic Republic of the,   Guatemala,   India,   Pakistan
 
 
NCT01883193
12-1672
OPP1055867 ( Other Grant/Funding Number: Bill & Melinda Gates Foundation )
U10HD076474-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of Colorado, Denver
University of Colorado, Denver
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Instituto de Nutricion de Centroamerica y Panama (INCAP)
  • Kinshasa School of Public Health
  • Jawaharlal Nehru Medical College
  • Aga Khan University
  • RTI International
Principal Investigator: Nancy Krebs, MD,MS University of Colorado, Denver
Principal Investigator: Michael Hambidge, MD, SciD University of Colorado, Denver
University of Colorado, Denver
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP