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| ID | Type | Description | Link |
|---|---|---|---|
| 191/IEC AMC/MAY 2021 | Other Identifier | Andhra Medical College Institutional Ethics Committee |
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| Name | Class |
|---|---|
| Andhra Medical College | OTHER_GOV |
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Question: How effective is fortified iodized salt in increasing serum concentrations of folate, B12 and iron among non-pregnant and non-lactating women of reproductive age?
Hypothesis: Micronutrient fortified iodized salt can increase serum levels (of folate, B12 and iron) and serve as a policy consideration in salt fortification with both iodine and other micronutrients to reduce serious and fatal birth defects.
Salt is an ideal vehicle for fortification because its universal consumption and often centrally processed with established distribution channels. Over 70% of households globally have access to iodized salt. Considering the success of salt iodization, it is logical to use the existing infrastructure to provide folic acid and other micronutrients (such as B12 and iron) through this dietary mechanism.
AIM:To assess increase in blood concentrations of folate, B12 and iron among women of reproductive age who consume micronutrient-fortified iodized salt for 3 months.
OBJECTIVES :
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micronutrient fortified iodized salt | Dietary Supplement | addition of folic acid, B12 and iron to iodized salt to be consumed daily and assess rise in serum levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Measure changes in median serum folate, B12 and iron levels between baseline and study endpoint | evaluate blood levels pre- and post-intake of study salt (fortified with folic acid, B12 and iron) | 2-6 months |
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Inclusion Criteria: • Willing to voluntarily participate in the study
Exclusion Criteria:
Women of childbearing age
Women of childbearing age who are non-lactating and willing to consume the study salt for the duration were recruited for voluntary participation into the study.
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| Name | Affiliation | Role |
|---|---|---|
| Jogi Pattisapu, MD | Pediatric Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Neurosurgery | Orlando | Florida | 32827 | United States | ||
| Andhra Medical College |
redacted information will be made available upon request.
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| Visakhapatnam |
| Andhra Pradesh |
| 530002 |
| India |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D005494 | Folic Acid Deficiency |
| D016135 | Spinal Dysraphism |
| C536410 | Neural tube defects X-linked |
| D014806 | Vitamin B 12 Deficiency |
| D000740 | Anemia |
| D000757 | Anencephaly |
| ID | Term |
|---|---|
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009008 | Abnormalities, Severe Teratoid |
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