An interventional study of MNP and preventive zinc supplement in Diarrhea, sponsored by University of California, Davis. Completed at 1 site in Laos. Open to participants aged 6 Months to 23 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-20.
Sponsored by University of California, Davis · Not applicable, Interventional, and Prevention
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.
Zinc is an essential nutrient that is required for children's normal growth and resistance to infections, including diarrhea and pneumonia, two major causes of child mortality. Current strategies for controlling the growth and infection-related complications of zinc deficiency include: 1) daily or weekly preventive zinc supplementation, and 2) therapeutic zinc supplementation for 10-14 days in relation to episodes of diarrhea. Information is needed on the relative impact of these intervention strategies on children's growth and risk of new episodes of diarrhea (and other infections).
Preventive zinc supplements can be delivered either as a single nutrient (zinc) supplement or as a multiple micronutrient (MMN) supplement, such as micronutrient powders (MNP) added to young children's complementary food. Available research indicates that zinc delivered in MNP at the currently recommended dose (4.1-5 mg/d) has not had a measurable impact on zinc-related functional outcomes, like growth and prevention of infection. Moreover, some studies of MMN supplements have detected a greater incidence of diarrhea in the MMN group than in the non-intervention or placebo control groups. Thus, despite the beneficial effects of MNP on prevention of anemia and enhancing iron status, questions have been raised about the desirability of providing zinc in MNP (containing iron and other nutrients) versus a single nutrient formulation offered between meals. For these reasons, the present study is designed to compare both the zinc delivery plan (i.e., preventive versus therapeutic supplementation) as well as the form of delivering zinc (i.e., as a dispersible tablet given between meals or as a MNP given with meals) and to permit assessment of any adverse effects of MNP on the incidence of diarrhea.
The study will be conducted as a community-based, randomized, placebo-controlled trial with four study groups in rural communities of Khammouane Province in Central Lao PDR.
The project team will enroll a total of \~3,400 children whose ages will range from 6-23 months. Children will be randomly assigned to one of four study group: 1) preventive zinc supplementation provided as LI-MNP plus ORS and placebo tablets for treatment of diarrhea; 2) placebo preventive supplementation provided as placebo powder plus ORS and placebo tablets for diarrhea ; 3) preventive zinc supplementation provided as dispersible zinc tablets (containing 7 mg zinc, to be given between meals) plus ORS and placebo tablets for diarrhea; and 4) therapeutic zinc supplementation provided as dispersible tablets (containing 20 mg zinc) for diarrhea plus ORS and placebo preventive tablets.
The major outcomes that will be monitored include adherence to the interventions; physical growth; incidence, duration and severity of episodes of diarrhea; changes in MN status; immune function; environmental enteric dysfunction; parasite burden; hair cortisol concentration; neuro-behavioral development; and the occurrence of any adverse events.
865 studies on the registry are indexed under Diarrhea; 77 are open to participants now.
This study's enrollment of 3,433 is above the median of 138 across 721 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →University of California, Davis is the lead sponsor of 809 studies on the registry; 145 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 43 (64%) have results posted.
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Exclusion Criteria:
preventive zinc supplements provided as MNP (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,) plus ORS and therapeutic placebo supplements for diarrhea
Dietary Supplement: MNP · Dietary Supplement: therapeutic placebo supplement
placebo powder plus ORS and therapeutic placebo supplements for diarrhea
Dietary Supplement: therapeutic placebo supplement · Dietary Supplement: placebo powder
preventive zinc supplements provided as dispersible zinc tablets (containing 7 mg zinc, to be given between meals) plus ORS and therapeutic placebo supplements for diarrhea
Dietary Supplement: preventive zinc supplement · Dietary Supplement: therapeutic placebo supplement
preventive placebo supplements provided as dispersible tablets plus ORS and dispersible therapeutic zinc tablets (containing 20 mg zinc) for diarrhea
Dietary Supplement: therapeutic zinc supplement · Dietary Supplement: preventive placebo supplement
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
7 mg zinc daily as dispersible tablet
20 mg zinc per day for 10 days during diarrhea episodes, as dispersible tablet
dispersible daily placebo tablet
dispersible placebo tablet for 10 days during diarrhea episodes
placebo powder
Change in length and length-for-age Z-score
Time frame: 36 weeks
Change in weight and weight-for-age Z-score
Time frame: 36 weeks
Incidence of diarrhea
Time frame: 36 weeks
Change in hemoglobin concentration
Time frame: 32 weeks
Change in micronutrient status
plasma zinc, ferritin, transferrin receptor; and retinol binding protein (RBP) concentrations, measured in a subsample of 560 participants, and controlling for the presence of elevated acute phase protein
Time frame: 32 weeks
Innate and adaptive immune defense
production of cytokines by cultures of peripheral blood white blood cells; and change in concentrations of naïve and memory CD4 and CD8 T-cells and regulatory (Treg) T-cells in a sub-set of 500 children
Time frame: 32 weeks
Change in mid-upper circumference
Time frame: 36 weeks
Achievement of gross motor developmental milestones
Gross motor developmental milestones as recommended by the World Health Organization include: sitting without support, crawling, standing with assistance, walking with assistance, standing alone, walking alone
Time frame: after 4, 8, 12, 16, 20, 24, 32 and 36 weeks
Change in stool calprotectin concentration
Time frame: 36 weeks
Change in stool neopterin concentration
Time frame: 36 weeks
Change in hair cortisol concentration
Time frame: 36 weeks
Intestinal protozoa parasite infection
Intestinal protozoan infections will be assessed by a modified formalin-ethyl acetate concentration technique
Time frame: 36 weeks
Helminths parasite infection
Helminth parasite infections will be assessed using duplicate Kato-Katz thick smears
Time frame: 36 weeks
Acute and chronic sleep pattern
Assessed by Brief Infant Child Sleep Questionnaire
Time frame: after 4, 8, 12, 16, 20, 24, 32 and 36 weeks
B-vitamin status
erythrocyte thiamine diphosphate, plasma folate and B12 concentrations and erythrocyte glutathione reductase activation coefficient (EGRac) measured in a randomly selected sub-sample of 260 children (MNP and control group only)
Time frame: 36 weeks
Incidence of serious adverse events
Serious adverse events, including death and required overnight stay in a health facility
Time frame: 36 weeks
Incidence of any non-serious adverse events
non-serious adverse events that may be detected retrospectively, such as the incidence of diarrhea, vomiting, etc., based on the results of morbidity surveillance
Time frame: 36 weeks
Plan to share: Yes — The complete de-identified dataset will be made publicly available within 3 years after completion of data collection. Associated data dictionaries will be made available along with the datasets.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Summer 2020
Access criteria: Publicly available
Data sharing details ↗ · osf.io
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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