NCT01183572

Brief Summary

The purpose of this study is to determine whether daily oral supplements of multivitamins (including vitamins B-complex, C and E) along with Iron and folic acid given to non-pregnant women results in lower prevalence of anemia in preparation for pregnancy when compared to daily iron and folic acid supplements or folic acid alone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
802

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

September 11, 2012

Status Verified

September 1, 2012

Enrollment Period

1.4 years

First QC Date

August 13, 2010

Last Update Submit

September 8, 2012

Conditions

Anemia

Keywords

multivitaminsfolateironpericonception

Outcome Measures

Primary Outcomes (1)

  • Anemia

    Anemia will be defined as hemoglobin \< 12gm/dL at 6 months of intervention. Hemoglobin concentration will also be analyzed as a continuous outcome.

    6 months following the start of the intervention

Secondary Outcomes (3)

  • Weight Gain during intervention

    6 months following the start of the intervention

  • Mid Upper Arm Circumference

    6 months following the start of the intervention

  • Peripheral malaria parasitemia

    6 months following the start of the intervention

Study Arms (3)

Folic Acid and Iron

ACTIVE COMPARATOR

0.4mg of folic acid and 30 mg elemental iron taken daily for 6 months

Dietary Supplement: Folic Acid and Iron

Folic Acid

PLACEBO COMPARATOR

0.4mg of folic acid taken daily for 6 months

Dietary Supplement: Folic Acid

Multivitamins, Folic Acid, and Iron

ACTIVE COMPARATOR

A multivitamin and micronutrient supplement that constitutes 1 RDA of Vitamins A (2500 IU), B1 (1.4 mg), B2 (1.4 mg), B6 (1.9 mg), B12 (2.6 ug), niacin (18 mg), C (70 mg), E (10 mg), and folic acid (0.4 mg)along with 30 mg of elemental iron taken daily for 6 months.

Dietary Supplement: Multivitamins, Folic Acid, and Iron

Interventions

Multivitamins, Folic Acid, and IronDIETARY_SUPPLEMENT

Daily oral dose containing 2500 IU Vitamin A, 1.4 mg Vitamin B1, 1.4 mg Vitamin B2, 2.6 mg Vitamin B12, 1.9 mg Vitamin B6, 18 mg Niacin, 70 mg Vitamin C, 14.9 IU Vitamin E, 30 mg elemental iron, 0.4 mg folic acid

Multivitamins, Folic Acid, and Iron
Folic Acid and IronDIETARY_SUPPLEMENT

Daily oral dose of 30 mg elemental iron, 0.4 mg folic acid

Folic Acid and Iron
Folic AcidDIETARY_SUPPLEMENT

Daily oral dose of 0.4 mg folic acid

Folic Acid

Eligibility Criteria

Age15 Years - 29 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Girls aged \> =15 years and \<= 29 years
  • Have not missed a menstrual period during recruitment (no amenorrhea)
  • Has not been pregnant or given birth within the last 6 months
  • Intend to stay in the study area for at least 6 months after enrollment
  • Have provided written informed consent

You may not qualify if:

  • Amenorrhea or confirmed pregnancy at screening or enrollment.
  • Has given birth within 6 months
  • Already taking long-term vitamin supplementation.
  • Any severe illness requiring hospitalization at screening or enrollment (women who have been deemed to have recovered will be eligible once they return home).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ifakara Health Institute

Rufiji, Tanzania

Location

Related Publications (1)

  • Gunaratna NS, Masanja H, Mrema S, Levira F, Spiegelman D, Hertzmark E, Saronga N, Irema K, Shuma M, Elisaria E, Fawzi W. Multivitamin and iron supplementation to prevent periconceptional anemia in rural tanzanian women: a randomized, controlled trial. PLoS One. 2015 Apr 23;10(4):e0121552. doi: 10.1371/journal.pone.0121552. eCollection 2015.

    PMID: 25905863DERIVED

MeSH Terms

Conditions

Anemia

Interventions

GeritolFolic AcidIron

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Wafaie W Fawzi, MD, DrPH

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

  • Honorati M Masanja, PhD

    Ifakara Health Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Department of Global Health and Population

Study Record Dates

First Submitted

August 13, 2010

First Posted

August 17, 2010

Study Start

August 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

September 11, 2012

Record last verified: 2012-09

Locations

TA(1)