Folate Deficiency, Neural Tube Defects
Conditions
Keywords
folic acid, iodine, salt, serum folate, red blood cell folate, prevention, folate insufficiency, Malnutrition, Nervous System Malformations, Spinal Dysraphism, Vitamin B9, Micronutrients
Brief summary
Question: How effective is fortified iodized salt with folic acid (FISFA) in increasing serum and red blood cell folate in non-lactating, non-pregnant women of reproductive age in the country of Zambia who do not have active food fortification with a folic acid program? Participants will: * Consume salt with folic acid instead of their regular salt for 6 months * Have a blood draw 4 times * Fill out surveys
Detailed description
The objective of this nonrandomized controlled intervention trial is to measure the effectiveness of fortified iodized salt with folic acid (FISFA) on increasing blood folate concentrations as a preventive measure against folate-sensitive neural tube defects (NTDs) in a non-fortifying country of Zambia. The main questions it aims to answer are: Aim 1: Measure the effectiveness of FISFA on increasing serum and red blood cell folate concentrations in women of reproductive age in a non-fortifying country. Aim 2: Assess the risk of neural tube defects by measuring folate insufficiency levels via serum and red blood cell concentrations in women of reproductive age in a non-fortifying country. Aim 3: Assess taste and color acceptability of FISFA by study population.
Interventions
DIETARY_SUPPLEMENTFortified Iodized Salt with Folic Acid (FISFA)
Addition of folic acid to iodized salt for daily consumption to assess folate levels.
Sponsors
University of Alabama at Birmingham
Centre for Infectious Disease Research in Zambia
Baylor College of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Voluntary participation in the study * Do not intend to get pregnant * Not lactating or pregnant * Live alone or with a partner if they can be compliant and not share the study salt. * Aged between 18 and 45 years
Exclusion criteria
* Pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure change in median and mean serum folate levels between baseline, month 1, month 3 and month 6 (endpoint) | 0-6 months | Evaluate folate blood levels pre and post intervention |
| Measure change in median and mean red blood cell folate levels between baseline, month 1, month 3 and month 6 (endpoint) | 0-6 months | Evaluate folate blood levels pre and post intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Descriptive analysis of acceptability of FISFA by participants (taste and color on Likert scale) | 1,3,6 months | Evaluate salt with folic acid acceptability using Likert scale (1-5, with 5 being the better outcome) |
| Measure of folate insufficiency via serum and RBC concentration | 0-6 months | Comparing folate insufficiency via serum and RBC concentration to recommended levels of 25.5 nmol/L (serum) and 906 nmol/L in RBC for WRA |
Countries
United States, Zambia
Contacts
CONTACTAnastasia A Smith, DrPH
CONTACTAnna Munger, MS
PRINCIPAL_INVESTIGATORAnastasia A Smith, DrPH
University of Alabama at Birmingham
Outcome results
None listed