We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Folic Acid–Fortified Iodized Salt and Serum Folate Levels in Reproductive-Aged Women of Rural India: A Nonrandomized Controlled Trial.
- Authors
Pattisapu, Jogi V.; Manda, Vijayasekhar V.; Kottakki, Madhu Narayana Rao; Kajana, Phani Madhavi; Kancherla, Vijaya; Bhaganagarapu, Hayagriva Rao; Veerappan, Vigneshwar; Ediga, Achuith; Mannar, Venkatesh; Diosady, Levente; Oakley Jr, Godfrey P.
- Abstract
Key Points: Question: Is folic acid–fortified iodized salt associated with increasing serum folate concentrations among nonpregnant and nonlactating women of reproductive age? Findings: This nonrandomized controlled trial of 83 female participants in rural India used a preintervention and postintervention design and found a statistically significant increase in the median serum folate concentration after 4 months of folic acid–fortified iodized salt consumption. Meaning: These findings suggest that folic acid–fortified iodized salt consumption may increase serum folate levels, which may in turn prevent folate deficiency leading to serious and fatal birth defects, especially spina bifida and anencephaly. This nonrandomized controlled trial assesses serum folate concentrations after consumption of folic acid–fortified iodized salt by nonpregnant, nonlactating women aged 18 to 45 years in rural India. Importance: India has a disproportionately high prevalence of neural tube defects, including spina bifida and anencephaly (SBA), causing a high number of stillbirths, elective pregnancy terminations, and child mortality; India contributes a large proportion of the global burden of SBA. Thirty years after folic acid was shown to be effective in reducing SBA prevalence, only about one-quarter of such births are prevented globally through cereal grain fortification. Objective: To determine the association of folic acid–fortified iodized salt with serum folate concentrations among nonpregnant and nonlactating women of reproductive age. Design, Setting, and Participants: This nonrandomized controlled trial using a preintervention and postintervention design was conducted in 4 rural villages in Southern India from July 1 to November 30, 2022. All households in the villages agreed to participate in the study. Preintervention and postintervention serum folate levels were analyzed among study participants at baseline and after 4 months, respectively. Intervention: Consumption of approximately 300 µg/d of folic acid using double fortified salt (folic acid plus iodine). Median serum folate concentrations were assessed at baseline and 4 months. Main Outcomes and Measures: Change in median serum folate levels between baseline and study end point as the primary outcome of the study. Results: A total of 83 nonpregnant nonlactating women aged 20 to 44 years (mean [SD] age, 30.9 [5.1] years) were eligible for the study and provided serum samples for analysis at baseline and the end point of the intervention. The median serum folate concentration increased from 14.6 (IQR, 11.2-20.6) nmol/L at baseline to 54.4 (IQR, 43.5-54.4) nmol/L at end of study, a 3.7-fold increase from baseline to study end point. Two-tailed Wilcoxon signed rank test showed the median difference in preintervention and postintervention serum folate concentrations to be highly significant (P <.001). The participants found the salt acceptable in color and taste. Conclusions and Relevance: Use of folic acid–fortified iodized salt was associated with increased serum folate concentrations in women of reproductive age. This novel evidence can inform public health policy to accelerate SBA prevention. Trial Registration: ClinicalTrials.gov Identifier: NCT06174883
- Subjects
INDIA; CHILDBEARING age; SELF-evaluation; STATISTICAL correlation; FOOD consumption; SPINA bifida; RESEARCH funding; STATISTICAL hypothesis testing; DATA analysis; ACADEMIC medical centers; FOLIC acid; IODINE; ANENCEPHALY; QUESTIONNAIRES; CLINICAL trials; DESCRIPTIVE statistics; DIETARY sodium; EXPERIMENTAL design; PRE-tests &; post-tests; RURAL conditions; STATISTICS; RESEARCH; ENRICHED foods; COLLECTION &; preservation of biological specimens; DATA analysis software
- Publication
JAMA Network Open, 2024, Vol 7, Issue 3, pe241777
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2024.1777