Community Trial of Zinc Supplementation on Preschool Child Mortality and Morbidity in Southern Nepal
NCT ID: NCT00109551
Last Updated: 2013-05-01
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
58000 participants
Study Classification
INTERVENTIONAL
Study Start Date
2001-10-31
Study Completion Date
2006-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this study is to determine whether daily supplementation of young children in Nepal with either zinc, iron-folic acid, or both can reduce mortality and morbidity. Young children in Nepal have numerous nutritional deficiencies and high rates of morbidity and mortality. Zinc and/or iron supplementation may be a cost-effective method for reducing these risks.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months
NCT00269542
Morbidity
Mortality
Diarrhea
+1 more
COMPLETED
NA
Delivery of Iron and Zinc Supplements: Evaluation of Interaction Effect on Biochemical and Clinical Outcomes
NCT00470158
Anemia
Diarrhea
Iron
COMPLETED
PHASE4
Impact of Preventive and Therapeutic Zinc Supplementation Programs Among Young Children
NCT00944359
Zinc Deficiency
Diarrhea
Malaria
COMPLETED
NA
Randomized Placebo-Controlled Trial (RPCT) of Maize/Zinc in Guatemala
NCT00098202
Nutrition
Pregnancy
COMPLETED
PHASE3
Effects of Iron and/or Zinc Supplementation in Mexican School Children Exposed to Lead
NCT02346188
Lead Poisoning
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Mortality rates among preschool age children in Nepal and many other developing countries remain high despite significant progress made over the past 20 years. There remain significant nutritional deficiencies in these populations, especially important are vitamin and mineral deficiencies.
Comparisons: In this study, we are comparing the morbidity and mortality experience for children 1-36 months of age randomized to one of four daily supplementation regimens: placebo, zinc alone, iron-folic acid alone, zinc + iron-folic acid.
Comparisons: In this study, we are comparing the morbidity and mortality experience for children 1-36 months of age randomized to one of four daily supplementation regimens: placebo, zinc alone, iron-folic acid alone, zinc + iron-folic acid.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Nutrition
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
FACTORIAL
Primary Study Purpose
PREVENTION
Blinding Strategy
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
zinc sulphate dietary supplement
Intervention Type
DRUG
iron sulphate-folic acid dietary supplement
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* All children 1-35 months of age living in 30 Village Development Committees of Sarlahi District in southern Nepal.
Exclusion Criteria
* Parent refusal
Minimum Eligible Age
1 Month
Maximum Eligible Age
36 Months
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
United States Agency for International Development (USAID)
FED
Sponsor Role
collaborator
Bill and Melinda Gates Foundation
OTHER
Sponsor Role
collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Sponsor Role
lead
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James M Tielsch, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States
Site Status
Cornell University Division of Nutritional Sciences
Ithaca, New York, United States
Site Status
Nepal Nutrition Intervention Project-Sarlahi
Kathmandu and Sarlahi District, , Nepal
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Nepal
References
Explore related publications, articles, or registry entries linked to this study.
Tielsch JM, Khatry SK, Stoltzfus RJ, Katz J, LeClerq SC, Adhikari R, Mullany LC, Shresta S, Black RE. Effect of routine prophylactic supplementation with iron and folic acid on preschool child mortality in southern Nepal: community-based, cluster-randomised, placebo-controlled trial. Lancet. 2006 Jan 14;367(9505):144-52. doi: 10.1016/S0140-6736(06)67963-4.
Reference Type
RESULT
Coles CL, Sherchand JB, Khatry SK, Katz J, Leclerq SC, Mullany LC, Tielsch JM. Nasopharyngeal carriage of S. pneumoniae among young children in rural Nepal. Trop Med Int Health. 2009 Sep;14(9):1025-33. doi: 10.1111/j.1365-3156.2009.02331.x. Epub 2009 Jun 28.
Reference Type
RESULT
Kordas K, Siegel EH, Olney DK, Katz J, Tielsch JM, Kariger PK, Khalfan SS, LeClerq SC, Khatry SK, Stoltzfus RJ. The effects of iron and/or zinc supplementation on maternal reports of sleep in infants from Nepal and Zanzibar. J Dev Behav Pediatr. 2009 Apr;30(2):131-9. doi: 10.1097/DBP.0b013e31819e6a48.
Reference Type
RESULT
Coles CL, Sherchand JB, Khatry SK, Katz J, Leclerq SC, Mullany LC, Tielsch JM. Zinc modifies the association between nasopharyngeal Streptococcus pneumoniae carriage and risk of acute lower respiratory infection among young children in rural Nepal. J Nutr. 2008 Dec;138(12):2462-7. doi: 10.3945/jn.108.095422.
Reference Type
RESULT
Kordas K, Siegel EH, Olney DK, Katz J, Tielsch JM, Chwaya HM, Kariger PK, Leclerq SC, Khatry SK, Stoltzfus RJ. Maternal reports of sleep in 6-18 month-old infants from Nepal and Zanzibar: association with iron deficiency anemia and stunting. Early Hum Dev. 2008 Jun;84(6):389-98. doi: 10.1016/j.earlhumdev.2007.10.007. Epub 2007 Nov 26.
Reference Type
RESULT
Tielsch JM, Khatry SK, Stoltzfus RJ, Katz J, LeClerq SC, Adhikari R, Mullany LC, Black R, Shresta S. Effect of daily zinc supplementation on child mortality in southern Nepal: a community-based, cluster randomised, placebo-controlled trial. Lancet. 2007 Oct 6;370(9594):1230-9. doi: 10.1016/S0140-6736(07)61539-6.
Reference Type
RESULT
Siegel EH, Stoltzfus RJ, Khatry SK, Leclerq SC, Katz J, Tielsch JM. Epidemiology of anemia among 4- to 17-month-old children living in south central Nepal. Eur J Clin Nutr. 2006 Feb;60(2):228-35. doi: 10.1038/sj.ejcn.1602306.
Reference Type
RESULT
Siegel EH, Stoltzfus RJ, Kariger PK, Katz J, Khatry SK, LeClerq SC, Pollitt E, Tielsch JM. Growth indices, anemia, and diet independently predict motor milestone acquisition of infants in south central Nepal. J Nutr. 2005 Dec;135(12):2840-4. doi: 10.1093/jn/135.12.2840.
Reference Type
RESULT
Katz J, Khatry SK, Leclerq SC, Mullany LC, Yanik EL, Stoltzfus RJ, Siegel EH, Tielsch JM. Daily supplementation with iron plus folic acid, zinc, and their combination is not associated with younger age at first walking unassisted in malnourished preschool children from a deficient population in rural Nepal. J Nutr. 2010 Jul;140(7):1317-21. doi: 10.3945/jn.109.119925. Epub 2010 May 19.
Reference Type
RESULT
Wu L, Katz J, Mullany LC, Haytmanek E, Khatry SK, Darmstadt GL, West KP Jr, LeClerq SC, Tielsch JM. Association between nutritional status and positive childhood disability screening using the ten questions plus tool in Sarlahi, Nepal. J Health Popul Nutr. 2010 Dec;28(6):585-94. doi: 10.3329/jhpn.v28i6.6607.
Reference Type
RESULT
Wu LA, Katz J, Mullany LC, Khatry SK, Darmstadt GL, LeClerq SC, Tielsch JM. The association of preterm birth and small birthweight for gestational age on childhood disability screening using the Ten Questions Plus tool in rural Sarlahi district, southern Nepal. Child Care Health Dev. 2012 May;38(3):332-40. doi: 10.1111/j.1365-2214.2011.01221.x. Epub 2011 Mar 6.
Reference Type
RESULT
Siegel EH, Kordas K, Stoltzfus RJ, Katz J, Khatry SK, LeClerq SC, Tielsch JM. Inconsistent effects of iron-folic acid and/or zinc supplementation on the cognitive development of infants. J Health Popul Nutr. 2011 Dec;29(6):593-604. doi: 10.3329/jhpn.v29i6.9896.
Reference Type
RESULT
Surkan PJ, Shankar M, Katz J, Siegel EH, Leclerq SC, Khatry SK, Stoltzfus RJ, Tielsch JM. Beneficial effects of zinc supplementation on head circumference of Nepalese infants and toddlers: a randomized controlled trial. Eur J Clin Nutr. 2012 Jul;66(7):836-42. doi: 10.1038/ejcn.2012.42. Epub 2012 May 9.
Reference Type
RESULT
Surkan PJ, Siegel EH, Patel SA, Katz J, Khatry SK, Stoltzfus RJ, Leclerq SC, Tielsch JM. Effects of zinc and iron supplementation fail to improve motor and language milestone scores of infants and toddlers. Nutrition. 2013 Mar;29(3):542-8. doi: 10.1016/j.nut.2012.09.003. Epub 2013 Jan 5.
Reference Type
RESULT
Surkan PJ, Charles MK, Katz J, Siegel EH, Khatry SK, LeClerq SC, Stoltzfus RJ, Tielsch JM. The role of zinc and iron-folic acid supplementation on early child temperament and eating behaviors in rural Nepal: a randomized controlled trial. PLoS One. 2015 Mar 30;10(3):e0114266. doi: 10.1371/journal.pone.0114266. eCollection 2015.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Antenatal Micronutrient Supplementation and Birth Weight
NCT00115271
COMPLETED
PHASE3
Zinc Absorption From Zinc Biofortified Rice in Bangladeshi Children
NCT04099849
UNKNOWN
NA
Zinc and Biobehavioral Development in Early Childhood
NCT00589264
COMPLETED
NA
Higher and Standard Doses of Enteral Zinc Supplementation in Very Preterm Infants
NCT06219525
RECRUITING
NA
The Efficacy of Zinc-biofortified Rice in Bangladeshi Children
NCT03079583
COMPLETED
NA
Long-term Effects of Iron and Zinc Supplementation During Infancy on Cognitive Performance and Growth
NCT00824304
COMPLETED
Micronutrient Supplementation in in Paediatric Pulmonary Tuberculosis
NCT00801606
COMPLETED
PHASE3
Zinc, Iron, Vitamin A and Psychosocial Care for Child Growth and Development
NCT02319499
COMPLETED
PHASE3
Zinc Bioavailability From Amaranth-enriched Maize Tortillas
NCT02208609
COMPLETED
NA
The Effectiveness of Micronutrient Supplements on Growth and Educational Achievement of Schoolchildren in Bangladesh
NCT00859911
UNKNOWN
NA
Weekly Zinc Chelate Supplementation on Children's Growth
NCT01911260
COMPLETED
PHASE2/PHASE3
Effects of Liquid Zinc Supplementation and Dispersible Zinc Tablets on Plasma Zinc Concentration
NCT00944853
COMPLETED
NA
Impact of Sprinkles on Infectious Morbidity When Moderate to Severe Pediatric Malnutrition Is Highly Prevalent
NCT00530374
COMPLETED
PHASE3
Effect of Sprinkles With and w/o Fe on Zn Absorption in Kenyan Toddlers
NCT02101723
COMPLETED
NA
Effects of EED on Zn Absorption and Retention in Children From a MNP
NCT02758444
COMPLETED
NA
Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA
NCT03523117
COMPLETED
PHASE3
Optimizing Iron Status While Minimizing Morbidity in HIV-infected Ugandan Children
NCT03596996
COMPLETED
NA
Impact of Host Iron Status and Iron Supplement Use on Erythrocytic Stage of Plasmodium Falciparum
NCT01027663
COMPLETED
NA
Impact of Iron/Folic Acid vs Folic Acid Supplements During Pregnancy on Maternal and Child Health
NCT02221752
COMPLETED
NA
Effect of Iron Source on the Growth of Enteric Pathogens
NCT05314062
COMPLETED
NA
Periconceptional Iron Supplementation in Rural Bangladesh
NCT00953134
COMPLETED
EARLY_PHASE1
Evaluation of Vitamin A and Zinc Supplementation on Malarial Morbidity
NCT01782001
COMPLETED
PHASE3
Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status
NCT06568315
RECRUITING
PHASE3
Impact of Low Dose Iron-containing Micronutrient Powders on Iron Status and Morbidity of Young Children in Ethiopia
NCT02479815
COMPLETED
NA
Zinc Absorption From SQ-LNS With and Without Phytase
NCT02668133
COMPLETED
NA