Efficacy of Weekly Versus Daily Folic Acid Supplementation

March 29, 2012 updated by: Dr. Reynaldo Martorell, Emory University
Investigate the efficacy of weekly versus daily of folic acid supplementation on improving folate, vitamin B12,

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment

460

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female
  • aged 15-49

Exclusion Criteria:

  • pregnant
  • lactating less than 3 months
  • severely anemic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
serum folate level
red blood cell folate

Secondary Outcome Measures

Outcome Measure
depression
blood pressure
homocysteine
ferritin
serum zinc
serum B12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Reynaldo Martorell, PHD, MPH, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

October 31, 2006

First Submitted That Met QC Criteria

October 31, 2006

First Posted (Estimate)

November 1, 2006

Study Record Updates

Last Update Posted (Estimate)

April 2, 2012

Last Update Submitted That Met QC Criteria

March 29, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205-2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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