JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
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A multicenter community study on the efficacy of double-fortified salt.

BACKGROUND: Iron and iodine deficiencies affect more than 30% of the world's population. Typical Indian diets contain adequate amounts of iron, but the bioavailability is poor. This serious limiting factor is caused by low intake of meat products rich in heme iron and intake of phytates in staple foods in the Indian diet, which inhibits iron absorption.

OBJECTIVE: To test the stability of double-fortified salt (DFS) during storage and to assess its efficacy in improving the iron and iodine status of the communities.

METHODS: The stability of both iodized salt and DFS during storage for a 2-year period was determined. The bioefficacy of DFS was assessed in communities covering three states of the country for a period of 1 year. This was a multicenter, single-blind trial covering seven clusters. The experimental group used DFS and the control group used iodized salt. The salts were used in all meals prepared for family members, but determination of hemoglobin by the cyanmethemoglobin method was performed in only two or three members per family, and not in children under 10 years of age (n = 393 and 436 in the experimental and control groups, respectively). The family size was usually four or five, with a male: female ratio of 1:1, consisting of two parents with two or three children. Hemoglobin was measured at baseline, 6 months (midpoint), and 12 months (endpoint). Urinary iodine was measured in only one cluster at baseline and endpoint. All the participants were dewormed at baseline, 6 months, and 12 months.

RESULTS: The iron and iodine in the DFS were stable during storage for 2 years. Over a period of 1 year, there was an increase of 1.98 g/dL of hemoglobin in the experimental group and 0.77 g/dL of hemoglobin in the control group; the latter increase may have been due to deworming. The median urinary iodine changed from 200 microg/dL at baseline to 205 microg/dL at the end of the study in the experimental group and from 225 microg/dL to 220 microg/dL in the control group. There was a statistically significant (p < .05) improvement in the median urinary iodine status of subjects who were iodine deficient (urinary iodine < 100 microg/L) in both the experimental and the control groups, a result showing that DFS was as efficient as iodized salt in increasing urinary iodine from a deficient to sufficient status. There was a statistically significant increase (p < .05) in hemoglobin in all seven clusters in the experimental group compared with the control.

CONCLUSIONS: The iron and iodine in the DFS are stable in storage for 2 years. The DFS has proved beneficial in the delivery of bioavailable iron and iodine.

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