Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05792241 |
Other study ID # |
1834465 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 26, 2023 |
Est. completion date |
May 1, 2024 |
Study information
Verified date |
May 2024 |
Source |
University of California, Davis |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The overarching objective of this two-phase project is to assess the effects of fortifying
iodized salt with folic acid on improving women's folate status and thereby reduce the risk
of neural tube defects (NTDs), which are highly prevalent in Ethiopia. The project will be
conducted in two phases. The purpose of Phase 1, described herein, is to complete formative
research in preparation for a community-based, randomized trial, which will be carried out in
Phase 2. The objectives of Phase 1 are to: 1) assess the hematological condition and
nutritional status with respect to folate, iodine, and other micronutrients among
non-pregnant women of reproductive age (WRA) in the study communities, and 2) measure
discretionary salt and dietary folate intakes of the women and their households.
Description:
Potentially eligible women of reproductive age (WRA) will be identified from existing
community census records and will be listed sequentially. A random number generator will be
used to select individual women from this list for possible participation in the Phase 1
studies. In cases where two or more WRA are selected from the same household (HH), one will
be randomly selected for possible participation in the study and the other(s) will be
replaced by a WRA from another HH, using the same random selection procedure. A member of the
study team will then visit the homes of women who are selected for possible participation in
Phase 1 to describe the study to them, assess their eligibility, and request their consent to
participate. In particular, the data collector will present an initial disclosure statement
concerning the screening interview and will then obtain descriptive information from verbally
consenting women on their age, general health status, address, cell phone number (if
available), and potential willingness to participate in the subsequent research studies. The
data collector will review the women's health history and determine their eligibility for the
Phase 1 study.
For women who found to be eligible to participate in the Phase 1 study, the field worker will
describe the purpose of the study, the study procedures and related risks and benefits, the
confidentiality of results, and the fact that participation is voluntary. After providing an
opportunity for women to consult with family members and ask any questions to the research
team, the field worker (in the presence of a neutral witness) will request written consent
from the women to participate in the study. Additional questions will be asked of consenting
women regarding their marital status, ethnicity, religion, educational level, and employment;
and their housing characteristics (housing construction, water source, sanitary facilities,
access to electricity and cell phone service); and selected HH assets.
All eligible, consenting women will be requested to report to the Chefe Donsa Health Center
or one of the local health posts within the next one or two days following the initial
screening interview for fasting blood collection, anthropometric assessment, additional
interviews, and scheduling of subsequent home visits by the study team for full-day dietary
observations to measure discretionary salt intake and folate intake and to initiate 24-hour
urine collections to measure sodium and iodine excretion. The fasting blood specimens will be
collected for a complete blood count and measurement of red blood cell (RBC) folate and serum
folate, unmetabolized folic acid, vitamin B12, holo-transcobalamin, methyl malonic acid,
other B vitamins, genetic polymorphisms that affect folate metabolism, thyroglobulin,
glucose, insulin, retinol binding protein (RBP), ferritin, soluble transferrin receptor,
C-reactive protein, and alpha-1 acid glycoprotein and to complete a malaria rapid diagnostic
test (RDT). Serum retinol will be measured in a subset of 40 women to establish the
relationship between serum retinol and RBP in the study population. Blood specimens may also
be collected from a subset of 20 women for possible metabolomics assays and natural killer
cell (immune function) assays. Women with a positive RDT and those subsequently found to have
anemia (Hb<13.2 g/dL, to adjust for altitude) will be referred to the local health facility
for treatment. Additional interviews will be completed to assess the women's birth history,
contraceptive use, and household food insecurity.
All women will participate in dietary assessments and 24-hour urine collections on one day
within four weeks of enrollment, and a randomly selected sub-set of 40 women will complete
these studies on a second day one-to-two weeks later. The purpose of the second set of
studies is to allow for calculation of intra-individual variation in intakes and urinary
sodium and iodine excretion, which is necessary to estimate the distribution of usual
discretionary salt and folate intake and urinary sodium and iodine excretion of the study
population. The dietary studies will involve a dietitian who will remain in the participant's
home throughout the day to weigh all foods included in mixed dishes and to weigh the amounts
served and consumed. Portions of each food will be collected to analyze these in the
laboratory for sodium and selected nutrient contents. The investigators The investigators
will also carry out HH salt disappearance studies over a period of one week using iodized
refined salt provided by the project to determine the rate of salt utilization in relation to
HH size. This information will be used to estimate the quantities of salt that we will need
to deliver during Phase 2.