Trial of Pre-Pregnancy Supplements (TOPPS)
|ClinicalTrials.gov Identifier: NCT01183572|
Recruitment Status : Completed
First Posted : August 17, 2010
Last Update Posted : September 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Dietary Supplement: Multivitamins, Folic Acid, and Iron Dietary Supplement: Folic Acid and Iron Dietary Supplement: Folic Acid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||802 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Trial of Pre-Pregnancy Supplements|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Active Comparator: Folic Acid and Iron
0.4mg of folic acid and 30 mg elemental iron taken daily for 6 months
Dietary Supplement: Folic Acid and Iron
Daily oral dose of 30 mg elemental iron, 0.4 mg folic acid
Placebo Comparator: Folic Acid
0.4mg of folic acid taken daily for 6 months
Dietary Supplement: Folic Acid
Daily oral dose of 0.4 mg folic acid
Active Comparator: Multivitamins, Folic Acid, and Iron
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
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
- Anemia [ Time Frame: 6 months following the start of the intervention ]Anemia will be defined as hemoglobin < 12gm/dL at 6 months of intervention. Hemoglobin concentration will also be analyzed as a continuous outcome.
- Weight Gain during intervention [ Time Frame: 6 months following the start of the intervention ]Weight gain during intervention will be defined as the difference in weight between weight at randomization and weight at 6 months of intervention.
- Mid Upper Arm Circumference [ Time Frame: 6 months following the start of the intervention ]
- Peripheral malaria parasitemia [ Time Frame: 6 months following the start of the intervention ]Peripheral malaria parasitemia will be defined as fever in the past 72 hours with any malaria parasitemia in peripheral blood.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01183572
|Ifakara Health Institute|
|Principal Investigator:||Wafaie W Fawzi, MD, DrPH||Harvard School of Public Health|
|Principal Investigator:||Honorati M Masanja, PhD||Ifakara Health Institute|