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| ID | Type | Description | Link |
|---|---|---|---|
| FISFA-Zambia-2025 | Other Identifier | University of Alabama at Birmingham |
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| Name | Class |
|---|---|
| Centre for Infectious Disease Research in Zambia | OTHER |
| Baylor College of Medicine | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FISFA arm | Experimental | Dietary Supplement: fortified iodized salt with folic acid (FISFA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fortified Iodized Salt with Folic Acid (FISFA) | Dietary Supplement | Addition of folic acid to iodized salt for daily consumption to assess folate levels. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure change in median and mean serum folate levels between baseline, month 1, month 3 and month 6 (endpoint) | Evaluate folate blood levels pre and post intervention | 0-6 months |
| Measure change in median and mean red blood cell folate levels between baseline, month 1, month 3 and month 6 (endpoint) | Evaluate folate blood levels pre and post intervention | 0-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive analysis of acceptability of FISFA by participants (taste and color on Likert scale) | Evaluate salt with folic acid acceptability using Likert scale (1-5, with 5 being the better outcome) | 1,3,6 months |
| Measure of folate insufficiency via serum and RBC concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anastasia A Smith, DrPH | Contact | 205-276-1067 | anastasia.arynchyna@childrensal.org | |
| Anna Munger, MS | Contact | amunger@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anastasia A Smith, DrPH | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Active, not recruiting | Birmingham | Alabama | 35294 | United States | |
Redacted information will be made available upon request.
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| ID | Term |
|---|---|
| D005494 | Folic Acid Deficiency |
| D009436 | Neural Tube Defects |
| D044342 | Malnutrition |
| D009421 | Nervous System Malformations |
| D016135 | Spinal Dysraphism |
| ID | Term |
|---|---|
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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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 |
| 0-6 months |
| Centre for Infectious Disease Research in Zambia |
| Recruiting |
| Lusaka |
| 10101 |
| Zambia |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006571 | Heterocyclic Compounds |