Zinc Deficiency Clinical Trial
— ZARIOfficial title:
The Efficacy of Zinc-biofortified Rice in Improving Zinc Status in Young Bangladeshi Children, a Double Blind Randomized Controlled Trial
Verified date | July 2021 |
Source | Swiss Federal Institute of Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To assess the efficacy of the zinc biofortified rice on plasma zinc concentrations in infants from a rural area of Bangladesh.
Status | Completed |
Enrollment | 520 |
Est. completion date | April 25, 2019 |
Est. primary completion date | April 25, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Months to 36 Months |
Eligibility | Inclusion Criteria: - 12-36 months of age (at baseline assessment) - Low plasma Zn concentration (<10.71 µmol/L) - Marginally stunted (height for age Z-score <-1.75) - The informed consent form has been read and signed by the caregiver (or has been read out to the caregiver in case of illiteracy) Exclusion Criteria: - Severe Anemia (Hb< 70 g/L) - Chronic or acute illness or other conditions that in the opinion of the Principle Investigator (PI) or co-researchers would affect Zn metabolism or would render the participant unable to comply with the protocol (based on self-reporting or diagnosed during screening) - Participants taking part in other studies requiring the drawing of blood - Not planning long-term residence in study site - Regular intake (>2 days) of iron-containing mineral and vitamin supplements or fortified foods within the last 2 months - Chronic use of drugs that affect the metabolism of Zn, including reducing absorption or increasing excretion; e.g., tuberculosis medications (ethambutal and isoniazides), drugs used as treatment for entamoeba hystolica (diiodohydroxyquin), drugs that reduce stomach acidity (H2 blockers and proton pump inhibitory), antidepressants (nialamide and socarboxazid), anti-inflammatory drugs (corticosteroids), diuretics (thiazides). |
Country | Name | City | State |
---|---|---|---|
Bangladesh | BRACU, Bangladesh | Dhaka | |
Switzerland | Swiss Federal Institute of Technology (ETH) | Zurich |
Lead Sponsor | Collaborator |
---|---|
Swiss Federal Institute of Technology | BRAC University, HarvestPlus |
Bangladesh, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | plasma zinc | Change of plasma zinc values from baseline to endpoint and 2 times within study period | 4 collection points in total. 2 fixed at start and end of intervention (week 1&36, T=1,4). 2 sparse random sampling points (RSP) in-between T=1-4. First RSP between 2-5 months (week 5-20 T=2). Second RSP between 5-8 months (week 21-32,T=3). | |
Secondary | Inflammatory markers | C reactive protein (CRP),alpha1-acid glycoprotein (AGP) | 4 collection points in total. 2 fixed at start and end of intervention (week 1&36, T=1,4). 2 sparse random sampling points (RSP) in-between T=1-4. First RSP between 2-5 months (week 5-20 T=2). Second RSP between 5-8 months (week 21-32,T=3). | |
Secondary | Length | Length (in cm) measurement for anthropometric (HAZ-scores). | 4 collection points in total. 2 fixed at start and end of intervention (week 1&36, T=1,4). 2 sparse random sampling points (RSP) in-between T=1-4. First RSP between 2-5 months (week 5-20 T=2). Second RSP between 5-8 months (week 21-32,T=3). | |
Secondary | Weight | Weight (in kg) measurement for anthropometric (HAZ-scores). | 4 collection points in total. 2 fixed at start and end of intervention (week 1&36, T=1,4). 2 sparse random sampling points (RSP) in-between T=1-4. First RSP between 2-5 months (week 5-20 T=2). Second RSP between 5-8 months (week 21-32,T=3). | |
Secondary | Morbidity | diarrhea and disease episodes will be recorded weekly throughout the study | Fixed assessment once a week for every participant throughout the intervention period (week 1-36). | |
Secondary | FADS analyses | FADS plasma analyses for zinc biomarker determination | Secondary analyses of collected plasma samples, in subset of participants (75 children from each group, random selected, matched baseline and endpoint samples) | |
Secondary | Iron status | Plasma ferritin | 4 collection points in total. 2 fixed at start and end of intervention (week 1&36, T=1,4). 2 sparse random sampling points (RSP) in-between T=1-4. First RSP between 2-5 months (week 5-20 T=2). Second RSP between 5-8 months (week 21-32,T=3). | |
Secondary | Iron status | Hemoglobin | 4 collection points in total. 2 fixed at start and end of intervention (week 1&36, T=1,4). 2 sparse random sampling points (RSP) in-between T=1-4. First RSP between 2-5 months (week 5-20 T=2). Second RSP between 5-8 months (week 21-32,T=3). |
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