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Antenatal Micronutrient Supplementation and Birth Weight

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00115271
First Posted: June 22, 2005
Last Update Posted: August 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Johns Hopkins University
Information provided by (Responsible Party):
Parul Christian, Johns Hopkins Bloomberg School of Public Health
  Purpose
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.

Condition Intervention Phase
Low Birth Weight Infant Mortality Pregnancy Nutritional Status Drug: Nutritional supplements Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Maternal Micronutrient Supplementation to Reduce Low Birth Weight and Infant and Maternal Morbidity in Rural Nepal

Resource links provided by NLM:


Further study details as provided by Parul Christian, Johns Hopkins Bloomberg School of Public Health:

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

Estimated Enrollment: 5000
Study Start Date: January 1999
Study Completion Date: May 2001
Primary Completion Date: May 2001 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00115271


Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Johns Hopkins University
Investigators
Principal Investigator: Parul Christian, DrPH Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 α-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.
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.
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.
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.
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.
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.

Responsible Party: Parul Christian, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00115271     History of Changes
Other Study ID Numbers: H.22.98.09.02.C1
First Submitted: June 21, 2005
First Posted: June 22, 2005
Last Update Posted: August 26, 2014
Last Verified: August 2014

Keywords provided by Parul Christian, Johns Hopkins Bloomberg School of Public Health:
Micronutrients
Supplementation
Pregnancy
Birth weight
Infant mortality

Additional relevant MeSH terms:
Body Weight
Birth Weight
Infant Death
Signs and Symptoms
Death
Pathologic Processes
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs


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