Goh Yvonne E, Duggal Mona, Das Reena, Manger Mari S, Jamwal Manu, Singh Bidhi L, Brar Gurjinder Kaur, Long Julie M, Westcott Jamie, Thompson Lauren, Arnold Charles D, Krebs Nancy F, Brown Kenneth H, McDonald Christine M
Division of Gastroenterology, Hepatology and Nutrition, Department of Pediatrics, University of California, San Francisco, CA, United States.
Post Graduate Institute of Medical Education & Research, Chandigarh, India.
Am J Clin Nutr. 2025 Jul;122(1):146-156. doi: 10.1016/j.ajcnut.2025.04.009. Epub 2025 Jun 6.
Innovative fortification solutions are needed to address micronutrient deficiencies, which remain highly prevalent among adult females in India.
The objective of this trial was to evaluate the effects of quintuply-fortified salt (QFS) compared with iodized salt on the micronutrient status of nonpregnant females of reproductive age (NPFRA) in Punjab, India.
We conducted a double-blind, randomized, controlled, community-based trial. A total of 998 NPFRA were randomly assigned to receive: 1) QFS with iron as encapsulated ferrous fumarate, zinc, vitamin B, folic acid, and iodine (eFF-QFS); 2) QFS with the same micronutrients, but iron as encapsulated ferric pyrophosphate plus ethylenediaminetetraacetic acid (eFePP-QFS); or 3) iodized salt. Biomarkers of micronutrient status were assessed at enrollment, 6 mo and 12 mo.
At enrollment, the prevalence of anemia, iron deficiency, hypozincemia, vitamin B insufficiency, and folate insufficiency among trial participants was 47.9%, 59.7%, 35.5%, 61.5%, and 69.7%, respectively. Mean household salt disappearance, measured at monthly home visits, was 6.0 g/adult female equivalent/day [95% confidence interval (CI): 5.9, 6.1] and did not vary across groups or time. At 6 mo, the odds of vitamin B insufficiency, folate insufficiency, and hypozincemia were, respectively, 80% [odds ratio (OR): 0.20; 95% CI: 0.13, 0.31], 86% (OR: 0.14; 95% CI: 0.09, 0.21), and 38% (OR: 0.62; 95% CI: 0.41, 0.93) lower in the eFF-QFS compared with the iodized salt group. Effects on vitamin B and folate status were sustained at 12 mo, and were comparable in the eFePP-QFS compared with the iodized salt group. There was a small, marginally significant, reduction in iron deficiency in the eFF-QFS compared with the iodized salt group at 6 (OR: 0.64; 95% CI: 0.42, 0.98; P = 0.08) and 12 mo (OR: 0.58; 95% CI: 0.35, 0.95; P = 0.06), but not in the eFePP-QFS compared with the iodized salt group. There were no groupwise differences in anemia at either time point.
Multiple micronutrient salt fortification may be an effective strategy to improve micronutrient status, especially vitamin B and folate, among NPFRA at high risk of deficiency.
This study was registered at clinicaltrials.gov, with NCT05166980 and at Clinical Trials Registry-India with CTRI/2022/02/040333.
需要创新的强化解决方案来解决微量营养素缺乏问题，在印度成年女性中，微量营养素缺乏仍然非常普遍。
本试验的目的是评估与碘盐相比，五重强化盐（QFS）对印度旁遮普邦育龄非妊娠女性（NPFRA）微量营养素状况的影响。
我们进行了一项双盲、随机、对照、基于社区的试验。总共998名NPFRA被随机分配接受：1）以富马酸亚铁包衣形式添加铁、锌、维生素B、叶酸和碘的QFS（eFF-QFS）；2）含有相同微量营养素，但铁为焦磷酸铁加乙二胺四乙酸包衣形式的QFS（eFePP-QFS）；或3）碘盐。在入组时、6个月和12个月时评估微量营养素状况的生物标志物。
入组时，试验参与者中贫血、缺铁、低锌血症、维生素B不足和叶酸不足的患病率分别为47.9%、59.7%、35.5%、61.5%和69.7%。通过每月家访测量的家庭平均盐消耗量为6.0克/成年女性当量/天[95%置信区间（CI）：5.9，6.1]，且在各组或不同时间没有差异。在6个月时，与碘盐组相比，eFF-QFS组维生素B不足、叶酸不足和低锌血症的几率分别降低了80%[比值比（OR）：0.20；95%CI：0.13，0.31]、86%（OR：0.14；95%CI：0.09，0.21）和38%（OR：0.62；95%CI：0.41，0.93）。对维生素B和叶酸状况的影响在12个月时持续存在，并且与碘盐组相比，eFePP-QFS组的影响相当。与碘盐组相比，eFF-QFS组在6个月时（OR：0.64；95%CI：0.42，0.98；P = 0.08）和12个月时（OR：0.58；95%CI：0.35，0.95；P = 0.06）缺铁情况有小幅但边缘显著的降低，但与碘盐组相比，eFePP-QFS组没有这种情况。在两个时间点的贫血情况在各组之间没有差异。
多种微量营养素盐强化可能是改善高缺乏风险的NPFRA微量营养素状况，特别是维生素B和叶酸状况的有效策略。
本研究在clinicaltrials.gov注册，注册号为NCT05166980，在印度临床试验注册中心注册，注册号为CTRI/2022/02/040333。
