Vitamin D Status of Pregnant Women and Their Children in Eau Claire, South Carolina

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 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.

Conditions

• Vitamin D Deficiency
• Pregnancy

Interventions

DRUG

cholecalciferol (vitamin D3)

randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day

DRUG

cholecalciferol

randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3

DRUG

cholecalciferol

cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.

Sponsors & Collaborators

• Thrasher Research Fund

  collaborator OTHER

• Medical University of South Carolina

  lead OTHER

Principal Investigators

• Carol L Wagner, MD · Medical University of South Carolina

• Stuart A Hamilton, M.D. · Eau Claire Cooperative Health Centers

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-01-31

Primary Completion

2009-07-31

Completion

2009-07-31

Countries

• United States

Study Locations