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Efficacy of Weekly Versus Daily Folic Acid Supplementation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00394862
Enrollment
460
Registered
2006-11-01
Start date
2006-01-31
Completion date
2006-07-31
Last updated
2012-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neural Tube Defects

Brief summary

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

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.

Interventions

DRUGmultivitamin

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 49 Years
Healthy volunteers
Yes

Inclusion criteria

* female * aged 15-49

Exclusion criteria

* pregnant * lactating less than 3 months * severely anemic

Design outcomes

Primary

MeasureTime frame
serum folate level
red blood cell folate

Secondary

MeasureTime frame
serum zinc
serum B12
homocysteine
depression
blood pressure
ferritin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026