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Blood Folate and Homocysteine Levels Following Administration of Folic Acid According to Different Daily Dosing Schedules:a Simulation of Food Fortification

This study has been completed.
Sponsor:
Collaborators:
Peking University
Ministry of Science and Technology of the People´s Republic of China
University of Florida
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00207558
First received: September 13, 2005
Last updated: July 12, 2006
Last verified: September 2005
History of Changes
  Purpose
The aim of this study is to examine whether the same total daily dosage of folic acid, when taken as a single daily dose or as multiple divided doses throughout the day, results in different blood folate and homocysteine levels at the conclusion of the study. Further, a comparison of blood folate and homocysteine levels among women taking daily low-dosage (100mcg) and standard- dosage (400mcg) folic acid with those of women taking daily or weekly high-dosage (4000mcg) folic acid will be conducted.

Condition Intervention
Neural Tube Defects - Spina Bifida and Anencephaly
 Drug: folic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Blood Folate and Homocysteine Levels Following Administration of Folic Acid According to Different Daily Dosing Schedules:a Simulation of Food Fortification

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:
Estimated Enrollment: 1100
  Eligibility
Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-women who have delivered a baby two to four years ago, whose child is still alive, who are not breast-feeding, who are not pregnant or planning to become pregnant within the next 9 months following enrollment, who are using an IUD for contraception, and who have not taken vitamin supplements during the past 3 months

Exclusion Criteria:

-women who have not delivered a baby two to four years ago, whose child is deceased, who are breast-feeding, who are currently pregnant or planning to become pregnant within the next 9 months following enrollment, who are not using an IUD for contraception, and who have taken vitamin supplements during the past 3 months

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207558

Locations
China, Hebei
Townships
Xianghe County, Hebei, China
Sponsors and Collaborators
Centers for Disease Control and Prevention
Peking University
Ministry of Science and Technology of the People´s Republic of China
University of Florida
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00207558     History of Changes
Other Study ID Numbers: CDC-NCBDDD-3970  U11/CCU015587-04-1  U11/CCU015586-05 
Study First Received: September 13, 2005
Last Updated: July 12, 2006
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Spinal Dysraphism
Neural Tube Defects
Anencephaly
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities
Abnormalities, Severe Teratoid
 Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016