Health Trials

Folic Acid Salt Study (FISFA Zambia)

ConditionsFolate DeficiencyNeural Tube Defects
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Alabama at Birmingham

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnant or lactating

Trial design

Design model

Single group

Treatments tested in this trial

  • Fortified Iodized Salt with Folic Acid (FISFA)

    Dietary supplement

    Addition of folic acid to iodized salt for daily consumption to assess folate levels.

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: FISFA armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
0-6 months
2

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

Time frame
0-6 months

Secondary outcomes

1

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)

Time frame
1,3,6 months
2

Measure of folate insufficiency via serum and RBC concentration

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

Time frame
0-6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Centre for Infectious Disease Research in Zambia

Collaborator

Baylor College of Medicine

Collaborator

Source ClinicalTrials.gov
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