Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412087
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2006-12-13
Brief Title:
Vitamin D Status of Pregnant Women and Their Children in Eau Claire South Carolina
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Vitamin D Status of Pregnant Women and Their Children in Eau Claire South Carolina A Prevalence and Supplementation Model for Community Health Care Centers in the US
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Science News October 2004 called vitamin D deficiency a silent epidemic in America with no group unaffected Using new guidelines of optimal vitamin D levels more than 90 of African American women now suffer from vitamin D deficiency Deficiency during pregnancy has profound effects on the developing fetus Other systems besides bones are affected by vitamin D deficiency including an increased risk of autoimmune diseases such as rheumatoid arthritis multiple sclerosis type I diabetes and certain cancers
This study proposes to examine and manage vitamin D levels in more than one thousand women in an underserved population in South Carolina The women will be from the patient population seeking OBGYN and Pediatric services through Eau Claire Cooperative Health Centers Inc ECCHC a network of ten clinics in three counties in the center of the state approximately 70 miles from Charleston SC ECCHC is one of approximately 1000 community health centers supported through Health and Human Services HHS Health Resources and Services Administrations HRSA Bureau of Primary Health Care
The research objectives for this project will be managed through the Pediatric Nutritional Sciences Research Center of the Childrens Research Institute at the Medical University of South Carolina Charleston SC in collaboration with ECCHC The research aims will evaluate vitamin D levels and possible contributing factors to the levels in pregnant women Women who present to ECCHC within the first trimester of pregnancy will be randomized to one of two doses of vitamin D supplementation shown to be effective in other groups Each pregnant mother will begin supplementation during the 12th week of pregnancy and will be followed closely throughout pregnancy for one year to determine the effectiveness of supplementation on vitamin D status overall health of mother and of her infant following delivery
We expect to observe severe vitamin D deficiency in a considerable percentage of the mothers and their infants who receive care at ECCHC especially those individuals with darker pigmentation When the extent of vitamin D deficiency within each racialethnic group is better defined and their supplementation requirements identified we will be better able to establish guidelines for supplementation and health maintenance and set policy recommendations for the dietary recommended intake of vitamin D Those women and their infants identified as deficient in vitamin D will be important in establishing community health care policies for vitamin D surveillance and supplementation strategies The results will allow us to implement specific dietary andor medical interventions aimed at correcting hypovitaminosis D in the population in this study and other similar populations being served by the more than 1000 community health centers nationally
This study proposes to examine and manage vitamin D levels in more than one thousand women in an underserved population in South Carolina The women will be from the patient population seeking OBGYN and Pediatric services through Eau Claire Cooperative Health Centers Inc ECCHC a network of ten clinics in three counties in the center of the state approximately 70 miles from Charleston SC ECCHC is one of approximately 1000 community health centers supported through Health and Human Services HHS Health Resources and Services Administrations HRSA Bureau of Primary Health Care
The research objectives for this project will be managed through the Pediatric Nutritional Sciences Research Center of the Childrens Research Institute at the Medical University of South Carolina Charleston SC in collaboration with ECCHC The research aims will evaluate vitamin D levels and possible contributing factors to the levels in pregnant women Women who present to ECCHC within the first trimester of pregnancy will be randomized to one of two doses of vitamin D supplementation shown to be effective in other groups Each pregnant mother will begin supplementation during the 12th week of pregnancy and will be followed closely throughout pregnancy for one year to determine the effectiveness of supplementation on vitamin D status overall health of mother and of her infant following delivery
We expect to observe severe vitamin D deficiency in a considerable percentage of the mothers and their infants who receive care at ECCHC especially those individuals with darker pigmentation When the extent of vitamin D deficiency within each racialethnic group is better defined and their supplementation requirements identified we will be better able to establish guidelines for supplementation and health maintenance and set policy recommendations for the dietary recommended intake of vitamin D Those women and their infants identified as deficient in vitamin D will be important in establishing community health care policies for vitamin D surveillance and supplementation strategies The results will allow us to implement specific dietary andor medical interventions aimed at correcting hypovitaminosis D in the population in this study and other similar populations being served by the more than 1000 community health centers nationally
Detailed Description:
With avoidance of sunlight exposure due to lifestyle changes and concerns regarding skin cancer and the resultant widespread use of sunscreen very few Americans are meeting their needs for vitamin D either through skin photosynthesis or dietary intake A study published by the Centers for Disease Control CDC and our laboratory at the Medical University of South Carolina MUSC revealed that 42 of African American women in their childbearing years exhibited a deficiency of D vitamin hypovitaminosis D 1 Using new guidelines of optimal vitamin D levels more than 90 of African American women now suffer from vitamin D deficiency 2 Science News October 2004 called vitamin D deficiency a silent epidemic in America with no group unaffected 3 Deficiency during pregnancy has profound effects on the developing fetus Vitamin D deficiency affects other systems besides bones it is associated with later lifelong sequelae with notable increased risk of autoimmune diseases such as rheumatoid arthritis 4 multiple sclerosis 56 type I diabetes 78 and certain cancers 79-14 Prevention and intervention studies only recently have been undertaken 3 A reexamination of dietary vitamin D requirements of various vulnerable populations in the US is desperately needed 23 As a representative community with a diverse population Eau Claire Cooperative Health Centers in South Carolina ECCHC serves a large percentage of African American as well as Caucasian and Hispanic women and children considered to be at high risk for vitamin D deficiency ECCHC has eight clinics providing 1o care services to patients with special emphasis on Pediatric and OBGYN services Defining the prevalence of vitamin D deficiency in this patient population and the optimal vitamin D supplementation strategies for these women and their infants will become the prototype for recommendations applicable to other communities throughout the US
In Specific Aim 1 the vitamin D status of a cross-sectional sample of 1000 pregnant women presenting at ECCHC for their prenatal care will be determined by measuring serum calcium phosphorus intact parathyroid hormone iPTH 25OHD the nutritional marker of vitamin D as a function of ethnicity Maternal health characteristics skin pigmentation using reflectance spectrophotometry dietary characteristics using an established food frequency questionnaire and lifestyle profiles using standardized questionnaires will be ascertained as well Any deficiency noted will lead to specific recommendations for vitamin D supplementation by the research team with standardized strategies to monitor status following initiation of supplementation in Specific Aim 2 Based on extensive preliminary data a supplementation regimen will be implemented and its efficacy in achieving optimal vitamin D status in these women tested in Aim 2 women within three racial groups African American Hispanic and Caucasian will be stratified into two groups by their initial 25OHD level Group 1 32 ngmL less than optimal vitamin D status and Group 2 32 ngmL optimal vitamin D status Based on our ongoing NIH study of pregnant women each group will be randomized to receive one of two doses starting at 13 weeks gestation 2000 or 4000 IU vitamin D3day after a universal one-month 2000 IUday dosing run-in period at 12 weeks balanced by raceethnicity The randomization schema allows determination of both efficacy and safety for those deficient and those replete at entry into the study as a function of raceethnicity and season
Anticipated Results and Future Studies We expect to observe vitamin D deficiency in a considerable percentage of the mothers and their newborn infants who receive care at ECCHC especially those individuals with darker pigmentation In Aims 1 2 by determining the prevalence of vitamin D deficiency with each racialethnic group we will establish guidelines for supplementation and health maintenance and policy recommendations for the dietary recommended intake of vitamin D in the US The results will allow us to implement specific dietary andor medical interventions aimed at correcting hypovitaminosis D in the population in this study and other similar populations being served by the more than 1000 community health centers nationally
In Specific Aim 1 the vitamin D status of a cross-sectional sample of 1000 pregnant women presenting at ECCHC for their prenatal care will be determined by measuring serum calcium phosphorus intact parathyroid hormone iPTH 25OHD the nutritional marker of vitamin D as a function of ethnicity Maternal health characteristics skin pigmentation using reflectance spectrophotometry dietary characteristics using an established food frequency questionnaire and lifestyle profiles using standardized questionnaires will be ascertained as well Any deficiency noted will lead to specific recommendations for vitamin D supplementation by the research team with standardized strategies to monitor status following initiation of supplementation in Specific Aim 2 Based on extensive preliminary data a supplementation regimen will be implemented and its efficacy in achieving optimal vitamin D status in these women tested in Aim 2 women within three racial groups African American Hispanic and Caucasian will be stratified into two groups by their initial 25OHD level Group 1 32 ngmL less than optimal vitamin D status and Group 2 32 ngmL optimal vitamin D status Based on our ongoing NIH study of pregnant women each group will be randomized to receive one of two doses starting at 13 weeks gestation 2000 or 4000 IU vitamin D3day after a universal one-month 2000 IUday dosing run-in period at 12 weeks balanced by raceethnicity The randomization schema allows determination of both efficacy and safety for those deficient and those replete at entry into the study as a function of raceethnicity and season
Anticipated Results and Future Studies We expect to observe vitamin D deficiency in a considerable percentage of the mothers and their newborn infants who receive care at ECCHC especially those individuals with darker pigmentation In Aims 1 2 by determining the prevalence of vitamin D deficiency with each racialethnic group we will establish guidelines for supplementation and health maintenance and policy recommendations for the dietary recommended intake of vitamin D in the US The results will allow us to implement specific dietary andor medical interventions aimed at correcting hypovitaminosis D in the population in this study and other similar populations being served by the more than 1000 community health centers nationally
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None