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

NCT00412087 | Completed Phase 3 Results DMC

• 1 other identifier: HR-16476
• Study Type: interventional
• Target: 564
• Locations: 1 country
• Sites: 1

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 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

Keywords

vitamin D; cholecalciferol; pregnant women

Outcome Measures

Primary Outcomes (1)

• 25-hydroxyvitamin D at Visit 7

  25-hydroxyvitamin D at Visit 7, one month prior to delivery

  7 months

Secondary Outcomes (1)

• Parathyroid Hormone at Visit 7

  7 months

Study Arms (2)

Cholecalciferol 2000 IU

EXPERIMENTAL

Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.

Drug: cholecalciferol (vitamin D3); Drug: cholecalciferol

Cholecalciferol 4000 IU

EXPERIMENTAL

Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day

Drug: cholecalciferol (vitamin D3); Drug: cholecalciferol

Interventions

cholecalciferol (vitamin D3) DRUG

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

Also known as: vitamin D3

Cholecalciferol 2000 IU; Cholecalciferol 4000 IU

cholecalciferol DRUG

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

Also known as: Vitamin D3

Cholecalciferol 2000 IU; Cholecalciferol 4000 IU

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

Eau Claire Cooperative Health Centers, Inc.

Columbia, South Carolina, 29203, United States

Location

Related Publications (4)

• Hollis BW, Wagner CL. Vitamin D deficiency during pregnancy: an ongoing epidemic. Am J Clin Nutr. 2006 Aug;84(2):273. doi: 10.1093/ajcn/84.1.273. No abstract available.

  PMID: 16895872 BACKGROUND

• Hollis BW, Wagner CL. Nutritional vitamin D status during pregnancy: reasons for concern. CMAJ. 2006 Apr 25;174(9):1287-90. doi: 10.1503/cmaj.060149. No abstract available.

  PMID: 16636329 BACKGROUND

• Hollis BW, Wagner CL. Vitamin D requirements during lactation: high-dose maternal supplementation as therapy to prevent hypovitaminosis D for both the mother and the nursing infant. Am J Clin Nutr. 2004 Dec;80(6 Suppl):1752S-8S. doi: 10.1093/ajcn/80.6.1752S.

  PMID: 15585800 BACKGROUND

• Hamilton SA, McNeil R, Hollis BW, Davis DJ, Winkler J, Cook C, Warner G, Bivens B, McShane P, Wagner CL. Profound Vitamin D Deficiency in a Diverse Group of Women during Pregnancy Living in a Sun-Rich Environment at Latitude 32 degrees N. Int J Endocrinol. 2010;2010:917428. doi: 10.1155/2010/917428. Epub 2010 Dec 9.

  PMID: 21197089 RESULT

Related Links

• Thrasher Research Foundation
• Medical University of South Carolina, Charleston, SC

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Carol Wagner
• Organization: Medical University of South Carolina

wagnercl@musc.edu

18437922112

Study Officials

• Carol L Wagner, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Stuart A Hamilton, M.D.

  Eau Claire Cooperative Health Centers

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: December 13, 2006
• First Posted: December 15, 2006
• Study Start: January 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 29, 2016
• Results First Posted: June 10, 2016

Record last verified: 2016-06

Locations

US (1)