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Antenatal Micronutrient Supplementation and Birth Weight

Primary Purpose

Low Birth Weight, Infant Mortality, Pregnancy

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Nutritional supplements
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Low Birth Weight focused on measuring Micronutrients, Supplementation, Pregnancy, Birth weight, Infant mortality

Eligibility Criteria

15 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Married women of reproductive age identified as a new pregnancy using a urine test Exclusion Criteria: Menopausal or sterilized woman or currently already pregnant or breastfeeding an infant <9 months of age

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Birth weight
    3-month infant mortality

    Secondary Outcome Measures

    Infant morbidity
    Maternal morbidity
    Maternal nutritional status
    Weight gain during pregnancy
    Infant growth

    Full Information

    First Posted
    June 21, 2005
    Last Updated
    August 22, 2014
    Sponsor
    Johns Hopkins Bloomberg School of Public Health
    Collaborators
    United States Agency for International Development (USAID), Bill and Melinda Gates Foundation, Johns Hopkins University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00115271
    Brief Title
    Antenatal Micronutrient Supplementation and Birth Weight
    Official Title
    Maternal Micronutrient Supplementation to Reduce Low Birth Weight and Infant and Maternal Morbidity in Rural Nepal
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1999 (undefined)
    Primary Completion Date
    May 2001 (Actual)
    Study Completion Date
    May 2001 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Johns Hopkins Bloomberg School of Public Health
    Collaborators
    United States Agency for International Development (USAID), Bill and Melinda Gates Foundation, Johns Hopkins University

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study was to determine the effects of providing supplements containing alternative combinations of micronutrients during pregnancy on birth weight and other infant and maternal health and nutritional outcomes in a rural area of Nepal.
    Detailed Description
    Maternal micronutrient deficiencies are common in the developing world and may influence intrauterine growth and fetal and neonatal health and survival. Currently, policies for antenatal supplementation beyond iron-folic acid are not in place in these settings. And yet, the efficacy of such supplementation strategies has not been well established. Specifically, it is not clear if multiple micronutrient combinations will enhance fetal growth and newborn health and survival compared to single or smaller combinations of micronutrients. Also, while birth weight may serve as a proxy measure of newborn health, infant morbidity and mortality needs direct examination. Comparisons: Pregnant women received daily folic acid, folic acid plus iron, folic acid plus iron plus zinc, or a multiple micronutrient supplement containing 11 other nutrients all with vitamin A compared to a control group that received only vitamin A.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Birth Weight, Infant Mortality, Pregnancy, Nutritional Status
    Keywords
    Micronutrients, Supplementation, Pregnancy, Birth weight, Infant mortality

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    5000 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Nutritional supplements
    Primary Outcome Measure Information:
    Title
    Birth weight
    Title
    3-month infant mortality
    Secondary Outcome Measure Information:
    Title
    Infant morbidity
    Title
    Maternal morbidity
    Title
    Maternal nutritional status
    Title
    Weight gain during pregnancy
    Title
    Infant growth

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Married women of reproductive age identified as a new pregnancy using a urine test Exclusion Criteria: Menopausal or sterilized woman or currently already pregnant or breastfeeding an infant <9 months of age
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Parul Christian, DrPH
    Organizational Affiliation
    Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35589346
    Citation
    Subedi S, Katz J, Erchick DJ, Verhulst A, Khatry SK, Mullany LC, Tielsch JM, LeClerq SC, Christian P, West KP, Guillot M. Does higher early neonatal mortality in boys reverse over the neonatal period? A pooled analysis from three trials of Nepal. BMJ Open. 2022 May 19;12(5):e056112. doi: 10.1136/bmjopen-2021-056112.
    Results Reference
    derived
    PubMed Identifier
    29605494
    Citation
    Eroglu A, Schulze KJ, Yager J, Cole RN, Christian P, Nonyane BAS, Lee SE, Wu LSF, Khatry S, Groopman J, West KP Jr. Plasma proteins associated with circulating carotenoids in Nepalese school-aged children. Arch Biochem Biophys. 2018 May 15;646:153-160. doi: 10.1016/j.abb.2018.03.025. Epub 2018 Mar 30.
    Results Reference
    derived
    PubMed Identifier
    28148680
    Citation
    Lee SE, Stewart CP, Schulze KJ, Cole RN, Wu LS, Yager JD, Groopman JD, Khatry SK, Adhikari RK, Christian P, West KP Jr. The Plasma Proteome Is Associated with Anthropometric Status of Undernourished Nepalese School-Aged Children. J Nutr. 2017 Mar;147(3):304-313. doi: 10.3945/jn.116.243014. Epub 2017 Feb 1.
    Results Reference
    derived
    PubMed Identifier
    26446483
    Citation
    West KP Jr, Cole RN, Shrestha S, Schulze KJ, Lee SE, Betz J, Nonyane BA, Wu LS, Yager JD, Groopman JD, Christian P. A Plasma alpha-Tocopherome Can Be Identified from Proteins Associated with Vitamin E Status in School-Aged Children of Nepal. J Nutr. 2015 Dec;145(12):2646-56. doi: 10.3945/jn.115.210682. Epub 2015 Oct 7.
    Results Reference
    derived
    PubMed Identifier
    23966331
    Citation
    Cole RN, Ruczinski I, Schulze K, Christian P, Herbrich S, Wu L, Devine LR, O'Meally RN, Shrestha S, Boronina TN, Yager JD, Groopman J, West KP Jr. The plasma proteome identifies expected and novel proteins correlated with micronutrient status in undernourished Nepalese children. J Nutr. 2013 Oct;143(10):1540-8. doi: 10.3945/jn.113.175018. Epub 2013 Aug 21.
    Results Reference
    derived
    PubMed Identifier
    21956955
    Citation
    Christian P, Morgan ME, Murray-Kolb L, LeClerq SC, Khatry SK, Schaefer B, Cole PM, Katz J, Tielsch JM. Preschool iron-folic acid and zinc supplementation in children exposed to iron-folic acid in utero confers no added cognitive benefit in early school-age. J Nutr. 2011 Nov;141(11):2042-8. doi: 10.3945/jn.111.146480. Epub 2011 Sep 28.
    Results Reference
    derived
    PubMed Identifier
    21177506
    Citation
    Christian P, Murray-Kolb LE, Khatry SK, Katz J, Schaefer BA, Cole PM, Leclerq SC, Tielsch JM. Prenatal micronutrient supplementation and intellectual and motor function in early school-aged children in Nepal. JAMA. 2010 Dec 22;304(24):2716-23. doi: 10.1001/jama.2010.1861.
    Results Reference
    derived
    PubMed Identifier
    19581544
    Citation
    Lee AC, Darmstadt GL, Khatry SK, LeClerq SC, Shrestha SR, Christian P. Maternal-fetal disproportion and birth asphyxia in rural Sarlahi, Nepal. Arch Pediatr Adolesc Med. 2009 Jul;163(7):616-23. doi: 10.1001/archpediatrics.2009.75.
    Results Reference
    derived
    PubMed Identifier
    18644934
    Citation
    Christian P, Darmstadt GL, Wu L, Khatry SK, Leclerq SC, Katz J, West KP Jr, Adhikari RK. The effect of maternal micronutrient supplementation on early neonatal morbidity in rural Nepal: a randomised, controlled, community trial. Arch Dis Child. 2008 Aug;93(8):660-4. doi: 10.1136/adc.2006.114009.
    Results Reference
    derived

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