Lao Zinc Study: Effects of Two Forms of Daily Preventive Zinc Versus Therapeutic Zinc Supplementation

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.

Conditions

• Diarrhea

Interventions

DIETARY_SUPPLEMENT

MNP

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

DIETARY_SUPPLEMENT

preventive zinc supplement

7 mg zinc daily as dispersible tablet

DIETARY_SUPPLEMENT

therapeutic zinc supplement

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

DIETARY_SUPPLEMENT

preventive placebo supplement

dispersible daily placebo tablet

DIETARY_SUPPLEMENT

therapeutic placebo supplement

dispersible placebo tablet for 10 days during diarrhea episodes

DIETARY_SUPPLEMENT

placebo powder

placebo powder

Sponsors & Collaborators

• Lao Tropical and Public Health Institute, Lao PDR

  collaborator UNKNOWN

• USDA, Western Human Nutrition Research Center

  collaborator FED

• University of British Columbia

  collaborator OTHER

• Khon Kaen University

  collaborator OTHER

• Nutrition International

  collaborator OTHER

• The Mathile Institute for the Advancement of Human Nutrition

  collaborator OTHER

• University of California, Davis

  lead OTHER

Principal Investigators

• Sonja Y Hess, PhD · University of California, Davis

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

23 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2017-05-31

Completion

2017-07-31

Countries

• Laos

Study Locations