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Clinical trial with the levonorgestrel intrauterine system to measure changes in hemoglobin and serum ferritin among anemic women in Kenya

Award Number: R01HD100497
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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PROJECT SUMMARY/ABSTRACT Anemia continues to disproportionately affect marginalized women in resource-poor countries. In Africa/SE Asia, over 270 million women of reproductive age are anemic. Iron deficiency anemia causes 18% of maternal deaths worldwide. Multiprong approaches are needed to reduce the prevalence of anemia and the negative impact on family health. Every menstrual cycle, women lose 14 to 19 mg of iron; this is iron that anemic women need to lead healthier lives. Though the relationships between iron loss from menstruation, absorption of dietary intake of iron, storing iron, and the impacts on hematologic parameters are complex, higher levels of menstrual blood loss are associated with lower hemoglobin values. The levonorgestrel intrauterine system is a highly effective contraceptive product that also generally reduces menstrual blood loss. In research spanning over four decades, the product consistently raises hemoglobin levels and increases iron stores in broad populations of women, but particularly for women with heavy menstrual bleeding. This product is not widely available in resource-poor countries, due to higher costs relative to other contraceptives. As a potential tool to alleviate anemia, the levonorgestrel intrauterine system has never been adequately tested. Previous research has never focused on anemic women, nor used proper scientific approaches to determine if the product can significantly increase hemoglobin and iron levels via reducing menstrual blood loss. The overall goal of the proposed research is to give anemic women in Kenya an opportunity to try the levonorgestrel intrauterine system and with improved scientific approaches, measure the impact on hemoglobin and iron stores. In this randomized trial, the comparison product will be oral contraceptives containing iron supplement pills, which are widely available and used in Kenya. If the levonorgestrel intrauterine system is found to work as hypothesized, then the product can become another tool to alleviate anemia among reproductive-aged women, resulting in healthier living and healthier beginnings to pregnancy when desired.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Child Health and Human Development Extramural Research	000	4	11/30/2023	NON-COMPETING CONTINUATION	$0
2024	2023	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Child Health and Human Development Extramural Research	001	4	7/9/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $497,514 )
2023	2023	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Child Health and Human Development Extramural Research	000	4	7/27/2023	NON-COMPETING CONTINUATION	$497,514
														Subtotal = $497,514

Issue Date FY: 2022 ( Subtotal = $499,315 )
2022	2022	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL STREET	DURHAM	NC	27701	DURHAM	USA	Child Health and Human Development Extramural Research	000	3	8/22/2022	NON-COMPETING CONTINUATION	$499,315
														Subtotal = $499,315

Issue Date FY: 2021 ( Subtotal = $513,093 )
2021	2021	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Child Health and Human Development Extramural Research	001	2	7/23/2021	NON-COMPETING CONTINUATION	$513,093
2021	2020	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Child Health and Human Development Extramural Research	000	1	7/21/2021	NEW	$0
														Subtotal = $513,093

Issue Date FY: 2020 ( Subtotal = $536,317 )
2020	2020	FAMILY HEALTH INTERNATIONAL	359 BLACKWELL ST STE 200	DURHAM	NC	27701	DURHAM	USA	Child Health and Human Development Extramural Research	000	1	7/21/2020	NEW	$536,317
														Subtotal = $536,317

Grand Total All Awards = $2,046,239

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Clinical trial with the levonorgestrel intrauterine system to measure changes in hemoglobin and serum ferritin among anemic women in Kenya

Award Number: R01HD100497

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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