Efficacy of Weekly Versus Daily Folic Acid Supplementation

Neural Tube Defects Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00394862
• Other study ID #: 205-2004
• Status: Completed
• Phase: N/A
• First received: October 31, 2006
• Last updated: March 29, 2012
• Start date: January 2006
• Est. completion date: July 2006

Study information

• Verified date: March 2012
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: July 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

Inclusion Criteria:

• female

• aged 15-49

Exclusion Criteria:

• pregnant

• lactating less than 3 months

• severely anemic

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neural Tube Defects
• Spinal Dysraphism

Intervention

Drug:
• multivitamin

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Centers for Disease Control and Prevention

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum folate level
Primary	red blood cell folate
Secondary	homocysteine
Secondary	ferritin
Secondary	serum zinc
Secondary	serum B12
Secondary	blood pressure
Secondary	depression