Feasibility, Acceptability and Directional Signal Effect on Blood Folate Levels of Iodized Salt Fortified With Folic Acid: Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Serum blood folate levels
研究概览
简要总结
Aim 1: Assess directional signal of effect of fortified salt with folic acid and iodine on blood serum folate levels.
It will be accomplished by feasibility pre-test/post-test clinical study by estimating mean and variability of serum blood folate levels effects of folic acid fortified salt.
Hypothesis: Fortified salt with folic acid and iodine will increase serum blood folate levels from baseline by month 1.
Aim 2: Assess feasibility and acceptability of salt fortified with folic acid and iodine.
Feasibility will be measured by 1) subjects' refusal rate of consent by 30 subjects during 6-month enrollment period; 2) method of determining salt consumption (weighting the saltshaker pre and post); 3) completion rates of study protocols from baseline to follow up. Hypothesis 1a: Completion of all blood draw visits will be 90-100%.
Acceptability will be measured by 1) completion rate of daily salt logs; 2) consumption of salt by weighting saltshakers; 3) attitude towards taste and color difference. Hypothesis 1b: Completion rate (90-100%) of daily salt logs will range from 90-100% of participants and 2) consumption of salt will range from 90-100% of participants.
Dietary surveys will be employed to document dietary habits and estimated daily FA intake in the sample population. Feasibility and acceptability of dietary surveys will be measured by willingness to answer survey questions. Hypothesis 1c: Completion rate of dietary surveys will range 90-100%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •consumes salt
排除标准
- •pregnant or intends to become pregnant in next 6 months
研究组 & 干预措施
Salt with folic acid and iodine
Intervention is intake of double fortified salt with folic acid and iodine (DFS). We will ask the participants to substitute their current salt with the study saltshaker and use it when preparing food or when eating out. We estimate minimum daily intake from salt consumption by participants will be 200 micrograms (µg) of folic acid per serving. Serving is 2g of salt. Participants will be given portion suggestions: 1/2 teaspoon or 2-3 pinches or 8-10 shakes/5 times a day. Containers (125g) will be weighted at the beginning and end of 1 month. We will ask each day if woman cooked/used the salt for herself only or to list number of people each day. Participants will also agree to complete either daily paper salt log. A commercially available salt that is fortified with folic acid has been provided by AlpenJodSalz produced by Sudwestdeutsche Salzwerk. For 30 participants, we will need 30 containers.
干预措施: Salt with folic acid and iodine (Dietary Supplement)
结局指标
主要结局
Serum blood folate levels
时间窗: One month
Change in serum blood folate levels from baseline to one month
次要结局
- Percent of participants who completed all study visits(one month)
- Measure of effect salt with folic acid had on taste of food using Likert scale(one month)
- Number of participants who are enrolled in the study(one month)
- Change in weight of salt shakers (in grams)(one month)
- Measure of whether the color of salt negatively affect their desire to use it daily using Likert Scale(one month)
研究者
Anastasia Arynchyna
Clinical Research Manager/ DrPH student
University of Alabama at Birmingham