Impact of Pre-pregnancy Micronutrient Supplementation on Maternal and Child Outcomes

Emory University

Status: Completed

Conditions: Anemia; Iron Deficiency; Intrauterine Growth Retardation; Preterm Delivery

Treatments: Dietary Supplement: Multiple Micronutrient; Dietary Supplement: Iron and Folic Acid; Dietary Supplement: Folic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01665378

IRB00051384

10-1196-UEMORY-01 (Other Identifier)

Details and patient eligibility

About

The study evaluates the efficacy of providing weekly iron-folate (IFA) supplements or Multiple Micronutrient (MM) supplements before pregnancy in increasing birth weight and duration of gestation as well as maternal and infant iron status.

Full description

Low birth weight and anemia remain intractable problems in many developing countries despite considerable efforts to address them. Intervening with just prenatal iron-folate (IFA) supplements may not be the best approach given the substantial demands for iron by maternal and fetal tissues. Therefore, there is an urgent need to evaluate the additional contribution of prepregnancy interventions.

The study evaluates the efficacy of providing weekly iron-folate (IFA) supplements or Multiple Micronutrient (MM) supplements before pregnancy in increasing birth weight and duration of gestation as well as maternal and infant iron status.

Enrollment: 5,011 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18-35 years old
• Currently married
• Currently living in one of the 10 communes and intends to live in the areas for 24 months following recruitment
• Plans to have children in the next year
• Agrees to participate with informed consent

Exclusion criteria

• Currently pregnant
• Delivered in the previous six months
• Regularly consumed IFA or MM supplements in the past 2 months
• Severe anemia (Hb < 7 g/L)
• History of high risk pregnancy including abruptio placenta, placenta previa, gestational diabetes, pregnancy induced hypertension, coagulation disorders, thrombocytopenia or chronic vascular, renal or systemic disease and drug use
• Chronic hematological diseases, hereditary defects of red cells or hemoglobin

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5,011 participants in 6 patient groups, including a placebo group

Multiple micronutrient - 1

Experimental group

Description:

The study population has been divided into 6 arms receiving 3 different pre-pregnancy interventions. The study uses a double blind design therefore the supplements are differentiated by a letter and a color: P/Purple, Q/Black, S/Brown, M/Green, T/Orange, H/Red. Multiple micronutrient groups 1 and 2 receive: Vitamin A (μg) 800 Vitamin D (IU) 600 Vitamin E (mg) 10 Vitamin C (mg) 70 Thiamine (mg) 1.4 Riboflavin (mg) 1.4 Niacin (mg) 18 Vitamin B6 (mg) 1.9 Vitamin B12 (μg) 2.6 Folic acid (μg)\* 2800 Iron (mg)\* 60 Zinc (mg) 15 Copper (mg) 2 Selenium (μg) 65 Iodine (μg) 150

Treatment:

Dietary Supplement: Multiple Micronutrient

Iron and folic acid - 1

Active Comparator group

Description:

The study population has been divided into 6 arms receiving 3 different pre-pregnancy interventions. The study uses a double blind design therefore the supplements are differentiated by a letter and a color: P/Purple, Q/Black, S/Brown, M/Green, T/Orange, H/Red. Iron and folic acid groups 1 and 2 receive: iron (60mg) and folic acid (2800μg), based on current WHO recommendations for WRA.

Treatment:

Dietary Supplement: Iron and Folic Acid

Folic Acid - 1

Placebo Comparator group

Description:

The study population has been divided into 6 arms receiving 3 different pre-pregnancy interventions. The study uses a double blind design therefore the supplements are differentiated by a letter and a color: P/Purple, Q/Black, S/Brown, M/Green, T/Orange, H/Red. Folic acid groups 1 and 2 receive: 2800 μg FA once a week during the pre-pregnancy period.

Treatment:

Dietary Supplement: Folic Acid

Multiple Micronutrient - 2

Experimental group

Description:

The study population has been divided into 6 arms receiving 3 different pre-pregnancy interventions. The study uses a double blind design therefore the supplements are differentiated by a letter and a color: P/Purple, Q/Black, S/Brown, M/Green, T/Orange, H/Red. Multiple micronutrient groups 1 and 2 receive: Vitamin A (μg) 800 Vitamin D (IU) 600 Vitamin E (mg) 10 Vitamin C (mg) 70 Thiamine (mg) 1.4 Riboflavin (mg) 1.4 Niacin (mg) 18 Vitamin B6 (mg) 1.9 Vitamin B12 (μg) 2.6 Folic acid (μg)\* 2800 Iron (mg)\* 60 Zinc (mg) 15 Copper (mg) 2 Selenium (μg) 65 Iodine (μg) 150

Treatment:

Dietary Supplement: Multiple Micronutrient

Iron and Folic Acid - 2

Active Comparator group

Description:

The study population has been divided into 6 arms receiving 3 different pre-pregnancy interventions. The study uses a double blind design therefore the supplements are differentiated by a letter and a color: P/Purple, Q/Black, S/Brown, M/Green, T/Orange, H/Red. Iron and folic acid groups 1 and 2 receive: iron (60mg) and folic acid (2800μg), based on current WHO recommendations for WRA.

Treatment:

Dietary Supplement: Iron and Folic Acid

Folic acid - 2

Placebo Comparator group

Description:

The study population has been divided into 6 arms receiving 3 different pre-pregnancy interventions. The study uses a double blind design therefore the supplements are differentiated by a letter and a color: P/Purple, Q/Black, S/Brown, M/Green, T/Orange, H/Red. Folic acid groups 1 and 2 receive: 2800 μg FA once a week during the pre-pregnancy period.

Treatment:

Dietary Supplement: Folic Acid