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Women First: Preconception Maternal Nutrition (WF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Colorado, Denver
Sponsor:
Collaborators:
University of San Carlos
Kinshasa School of Public Health
Jawaharlal Nehru Medical College
Aga Khan University
RTI International
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01883193
First received: June 18, 2013
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Maternal Malnutrition
Growth Failure
Mortality
Morbidity
Stunting
Dietary Supplement: Comprehensive Maternal Nutrition Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Women First: Preconception Maternal Nutrition

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Neonatal linear growth [ Time Frame: 48 hours of age ] [ Designated as safety issue: No ]
    Research assistants will obtain neonatal length measurement at 2 days of age.


Secondary Outcome Measures:
  • Length-for-age Z-scores [ Time Frame: age 0.5, 1, 3 and 6 months postnatal ] [ Designated as safety issue: No ]
    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 fetal growth [ Time Frame: 12 weeks gestation ] [ Designated as safety issue: No ]
    Ultrasound measurements will be undertaken at 12 weeks gestation with the goals of confirming gestational age and estimating fetal growth.

  • Mean birth weight and incidence of low birth weight (LBW) infants [ Time Frame: at birth ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 5760
Study Start Date: August 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Preconception
Arm 1 will commence the comprehensive maternal nutrition intervention at 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 BMI calculated. If BMI <19 an additional supplement will be provided. Menstrual history will be obtained at each visit and a urine pregnancy test will be performed if menses is delayed.
Dietary Supplement: Comprehensive Maternal Nutrition Intervention
The nutrition intervention will be delivered before conception or at 12 weeks gestation 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 2: Pregnancy
Participants in Arm 2 will commence the comprehensive maternal nutrition intervention at 12 weeks gestation.
Dietary Supplement: Comprehensive Maternal Nutrition Intervention
The nutrition intervention will be delivered before conception or at 12 weeks gestation 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
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   16 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 16-35 years of age;
  • 0-3 children;
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01883193

Contacts
Contact: Michael Hambidge, MD, ScD 303.724.3261 Michael.Hambidge@ucdenver.edu
Contact: Nancy Krebs, MD, MS 303-724-3260 Nancy.Krebs@ucdenver.edu

Locations
Congo, The Democratic Republic of the
Kinshasa School of Public Health Not yet recruiting
Kinshasa, Congo, The Democratic Republic of the
Contact: Antoinette Tshefu, MD    243 810 156 910    antoshe@yahoo.com   
Contact: Carl Bose, MD         
Principal Investigator: Antoinette Tshefu, MD         
Guatemala
FANCAP / San Carlos University Recruiting
Guatemala City, Guatemala
Contact: Ana Garcés, MD, MPH    502 2332-4064    anagarces@imsalud.org   
Contact: Lester Figueroa, MD    502 5555-2325    lesterfigueroa@me.com   
Principal Investigator: Ana Garces, MD         
India
Jawaharlal Nehru Medical College Recruiting
Belgaum, India, 590 010
Contact: Shivaprasad S. Goudar, MD, MHPE    91 831 244 4194    sgoudar@jnmc.edu   
Contact: Sangappa Dhaded, MD    91 831 247 1465    drdhadedsm@gmail.com   
Principal Investigator: Shivaprasad S. Goudar, MD, MHPE         
Pakistan
Aga Khan University Recruiting
Karachi, Pakistan
Contact: Omrana Pasha, MD    92-21-486 4948    omrana.pasha@aku.edu   
Contact: Sumera Ali    92-33 2-355-0437    sumera.ali@aku.edu   
Principal Investigator: Omrana Pasha, MD         
Sponsors and Collaborators
University of Colorado, Denver
University of San Carlos
Kinshasa School of Public Health
Jawaharlal Nehru Medical College
Aga Khan University
RTI International
Investigators
Principal Investigator: Michael Hambidge, MD, ScD University of Colorado, Denver
Principal Investigator: Nancy Krebs, MD, MS University of Colorado, Denver
  More Information

No publications provided by University of Colorado, Denver

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01883193     History of Changes
Other Study ID Numbers: 12-1672, OPP1055867, U10HD076474-01
Study First Received: June 18, 2013
Last Updated: March 25, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Colorado, Denver:
preconception maternal nutrition
LBW
Length-for-age
maternal nutrition supplement
multi-micronutrient fortified lipid-based supplement
infant growth
low-resource settings

Additional relevant MeSH terms:
Failure to Thrive
Malnutrition
Nutrition Disorders
Signs and Symptoms
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014