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Efficacy of Weekly Versus Daily Folic Acid Supplementation

This study has been completed.
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Dr. Reynaldo Martorell, Emory University
ClinicalTrials.gov Identifier:
NCT00394862
First received: October 31, 2006
Last updated: March 29, 2012
Last verified: March 2012
History of Changes

October 31, 2006
March 29, 2012
January 2006
June 2006   (final data collection date for primary outcome measure)
  • serum folate level
  • red blood cell folate
Same as current
Complete list of historical versions of study NCT00394862 on ClinicalTrials.gov Archive Site
  • homocysteine
  • ferritin
  • serum zinc
  • serum B12
  • blood pressure
  • depression
Same as current
Not Provided
Not Provided
 
Efficacy of Weekly Versus Daily Folic Acid Supplementation
Not Provided

Investigate the efficacy of weekly versus daily of folic acid supplementation on improving folate, vitamin B12,

460 women of a rural community in the western highlands of Guatemala were recruited for participation in the double-blinded study led by Emory University and the Institute of Nutrition of Central America and Panama (INCAP). The women were randomly assigned one of 4 vitamin treatments containing different levels of folic acid, Vitamin B12, iron and zinc. The treatments were as follows:

  1. weekly dose of folic acid at 5000ug, iron at 120 mg, zinc at 30mg, and B12 at 16.8 ug;
  2. weekly dose of folic acid at 2800ug, iron at 120mg, zinc at 0mg and B12 at 16.8ug;
  3. daily dose of folic acid at 400ug, iron at 60mg, zinc at 15mg, B12 at 2.4ug; and
  4. daily dose of folic acid at 200ug, iron at 50mg, zinc at 0mg, and B12 at 2.4ug.

The women, aged 15-49, received the vitamins daily for 3 months. Anthropometric data and blood samples were taken at baseline and post-supplementation. The participants also completed a series of dietary interviews at baseline and post-intervention. No pregnant or lactating mothers were admitted into the study, nor severely anemic females. Blood samples were sent to the National Laboratory in Cuernavaca, Mexico, for analysis of serum folate levels.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Neural Tube Defects
Drug: multivitamin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
460
July 2006
June 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • female
  • aged 15-49

Exclusion Criteria:

  • pregnant
  • lactating less than 3 months
  • severely anemic
Female
15 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00394862
205-2004
Not Provided
Dr. Reynaldo Martorell, Emory University
Emory University
Centers for Disease Control and Prevention
Principal Investigator: Reynaldo Martorell, PHD, MPH Emory University
Emory University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP