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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
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
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

No publications provided by Centers for Disease Control and Prevention

Additional 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
Anencephaly
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Abnormalities, Severe Teratoid
Congenital Abnormalities
Folic Acid
Vitamin B Complex
 Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013