Vitamin D Status of Pregnant Women and Their Children in Eau Claire, South Carolina
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00412087|
Recruitment Status : Completed
First Posted : December 15, 2006
Results First Posted : June 10, 2016
Last Update Posted : July 29, 2016
|First Submitted Date ICMJE||December 13, 2006|
|First Posted Date ICMJE||December 15, 2006|
|Results First Submitted Date||May 4, 2016|
|Results First Posted Date||June 10, 2016|
|Last Update Posted Date||July 29, 2016|
|Study Start Date ICMJE||January 2007|
|Actual Primary Completion Date||July 2009 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||25-hydroxyvitamin D at Visit 7 [ Time Frame: 7 months ]
25-hydroxyvitamin D at Visit 7, one month prior to delivery
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00412087 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Parathyroid Hormone at Visit 7 [ Time Frame: 7 months ]
Intact parathyroid hormone at Visit 7, one month prior to delivery
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Vitamin D Status of Pregnant Women and Their Children in Eau Claire, South Carolina|
|Official Title ICMJE||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 U.S.|
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 OB/GYN 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 Administration's (HRSA), Bureau of Primary Health Care.
The research objectives for this project will be managed through the Pediatric Nutritional Sciences Research Center of the Children's 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 racial/ethnic 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 and/or 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.
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 (5,6), type I diabetes (7,8), and certain cancers (7,9-14). Prevention and intervention studies only recently have been undertaken (3). A reexamination of dietary vitamin D requirements of various vulnerable populations in the U.S. is desperately needed (2,3). 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 OB/GYN 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 U.S.
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), 25(OH)D, 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 25(OH)D level: Group 1, <32 ng/mL (less than optimal vitamin D status) and Group 2, ≥32 ng/mL (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: 2,000 or 4,000 IU vitamin D3/day after a universal one-month 2,000 IU/day dosing run-in period at 12 weeks' balanced by race/ethnicity. 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 race/ethnicity 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 racial/ethnic group, we will establish guidelines for supplementation and health maintenance, and policy recommendations for the dietary recommended intake of vitamin D in the U.S. The results will allow us to implement specific dietary and/or 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 Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Enrollment ICMJE
|Actual Study Completion Date||July 2009|
|Actual Primary Completion Date||July 2009 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
Aim 1: Any mother who presents to her obstetrician or midwife at Eau Claire with confirmation of a singleton pregnancy will be eligible for enrollment in Aim 1.
Aim 2: If the mother also is <12 completed weeks of gestation, she will be eligible for participation of Aim 2 of the study. Mothers of diverse ethnic background (African-American, Asian, Caucasian, Asian and Hispanic) actively will be recruited. There are no age exclusion criteria.
Aim 1: There are no exclusion criteria.
Aim 2: Mothers with pre-existing calcium, parathyroid conditions or who require chronic diuretic or cardiac medication therapy including calcium channel blockers will not be eligible for enrollment into the study. Mothers with active thyroid disease (e.g., Graves, Hashimoto's or thyroiditis) will not be eligible to participate in the study; however, mothers on thyroid supplement with normal serological parameters may participate in the study if they are without any other endocrine dysfunction. Mothers with diabetes will not be excluded from participation in the study as vitamin D deficiency appears linked with insulin resistance and may aggravate the maternal condition.
|Ages||16 Years to 45 Years (Child, Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00412087|
|Other Study ID Numbers ICMJE||HR-16476|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Carol Wagner, Medical University of South Carolina|
|Study Sponsor ICMJE||Medical University of South Carolina|
|Collaborators ICMJE||Thrasher Research Fund|
|PRS Account||Medical University of South Carolina|
|Verification Date||June 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP