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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00109551
Other study ID # R01HD038753
Secondary ID R01HD038753
Status Completed
Phase Phase 3
First received April 28, 2005
Last updated April 30, 2013
Start date October 2001
Est. completion date January 2006

Study information

Verified date January 2006
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentNepal: Nepal Health Research Council
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 58000
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 1 Month to 36 Months
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
zinc sulphate dietary supplement

iron sulphate-folic acid dietary supplement


Locations

Country Name City State
Nepal Nepal Nutrition Intervention Project-Sarlahi Kathmandu and Sarlahi District
United States Johns Hopkins Bloomberg School of Public Health Baltimore Maryland
United States Cornell University Division of Nutritional Sciences Ithaca New York

Sponsors (3)

Lead Sponsor Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Bill and Melinda Gates Foundation, United States Agency for International Development (USAID)

Countries where clinical trial is conducted

United States,  Nepal, 

References & Publications (14)

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 — View Citation

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 — View Citation

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 — View Citation

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 — View Citation

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; — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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 O — View Citation

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-randomis — View Citation

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 — View Citation

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 — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Death among children 1-36 months of age
Secondary Incidence rates of selected morbidities including diarrhea, dysentery, acute respiratory infections
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