Community Trial of Zinc Supplementation on Preschool Child Mortality and Morbidity in Southern Nepal

NCT00109551 | Completed Phase 3

• 1 other identifier: R01HD038753
• Study Type: interventional
• Target: 58,000
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Nutrition

Keywords

zinc; child mortality; child morbidity; community trial; prevention trial; dietary supplement

Outcome Measures

Primary Outcomes (1)

• Death among children 1-36 months of age

Secondary Outcomes (1)

• Incidence rates of selected morbidities including diarrhea, dysentery, acute respiratory infections

Interventions

zinc sulphate dietary supplement DRUG

iron sulphate-folic acid dietary supplement DRUG

Eligibility Criteria

• Age: 1 Month - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All children 1-35 months of age living in 30 Village Development Committees of Sarlahi District in southern Nepal.

You may not qualify if:

• Parent refusal

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead
• United States Agency for International Development (USAID): collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (3)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205-2103, United States

Location

Cornell University Division of Nutritional Sciences

Ithaca, New York, 14853, United States

Location

Nepal Nutrition Intervention Project-Sarlahi

Kathmandu and Sarlahi District, Nepal

Location

Related Publications (16)

• 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.

  PMID: 16413878 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.

  PMID: 19563428 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.

  PMID: 19322104 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.

  PMID: 19022973 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.

  PMID: 18022771 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.

  PMID: 17920918 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.

  PMID: 16234835 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.

  PMID: 16317129 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.

  PMID: 20484548 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.

  PMID: 21261204 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.

  PMID: 21375569 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.

  PMID: 22283033 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.

  PMID: 22569086 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.

  PMID: 23298972 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.

  PMID: 25821959 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.

  PMID: 21956955 DERIVED

Study Officials

• James M Tielsch, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 28, 2005
• First Posted: April 29, 2005
• Study Start: October 1, 2001
• Study Completion: January 1, 2006
• Last Updated: May 1, 2013

Record last verified: 2006-01

Locations

US (2); NE (1)