CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,433 enrolled
Drug / intervention
MNP +5 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02428647
NCT02428647N/ACompleted
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Lao Zinc Study: The Effects of Two Forms of Daily Preventive Zinc Supplementation Versus Therapeutic Zinc Supplementation for Diarrhea on Young Children's Physical Growth and Risk of New Episodes of Diarrhea

University of California, Davis·interventional·Posted Apr 29, 2015·Updated Jan 20, 2022

In Brief

A clinical study evaluating MNP, preventive zinc supplement, and 4 other interventions for Diarrhea. Completed, enrolled 3,433 participants across 1 site.

Detailed Summary

The study will be conducted as a community-based, randomized, placebo-controlled, trial with four study groups. The overall objective of the study is to determine the optimal method for delivering zinc to young children, both for the prevention of zinc deficiency and treatment of diarrhea. In particular, the investigators plan to compare the impact on physical growth, morbidity, micronutrient status, immune function, environmental enteric dysfunction, parasite burden and hair cortisol concentration of: 1) daily preventive zinc supplementation as a micronutrient powder (MNP); 2) placebo powders; 3) daily preventive zinc supplementation as dispersible tablets; 4) therapeutic zinc supplementation as dispersible tablets given in relation to episodes of diarrhea. In addition to the major outcomes mentioned above, the investigators will monitor adherence to the interventions, neuro-behavioral development, and the occurrence of any adverse events.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiarrhea
CountriesLaos
CollaboratorsLao Tropical and Public Health Institute, USDA, Western Human Nutrition Research Center, University of British Columbia, Khon Kaen University, Nutrition International, The Mathile Institute for the Advancement of Human Nutrition

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 29, 2015
Enrollment StartSep 1, 2015
Primary CompletionMay 1, 2017
Study CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.2 years ago

Interventions

MNPdietary

MNP containing containing 10 mg zinc and 14 other nutrients, including 6 mg iron, 0.56 mg copper, 17 μg selenium, 90 μg iodine, 400 μg RE vitamin A, 5 μg vitamin D, 5 mg vitamin E, 30 mg ascorbic acid, 0.5 mg vitamin B1, 0.5 mg vitamin B2, 6 mg niacin, 0.5 mg vitamin B6, 0.9 μg vitamin B12, and 150 μg folate

preventive zinc supplementdietary

7 mg zinc daily as dispersible tablet

therapeutic zinc supplementdietary

20 mg zinc per day for 10 days during diarrhea episodes, as dispersible tablet

preventive placebo supplementdietary

dispersible daily placebo tablet

therapeutic placebo supplementdietary

dispersible placebo tablet for 10 days during diarrhea episodes

placebo powderdietary

placebo powder