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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665378
• Other study ID #: IRB00051384
• Secondary ID: 10-1196-UEMORY-0
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: December 2019

Study information

• Verified date: July 2021
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5011
• Est. completion date: December 2019
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Fetal Growth Retardation
• Intrauterine Growth Retardation
• Iron Deficiency
• Premature Birth
• Preterm Delivery

Intervention

Dietary Supplement:
• Multiple Micronutrient
There is no current recommendation for weekly MM supplements for WRA. Therefore, we propose a supplement that contains: The same amounts of iron and folic acid as the weekly, pre-natal IFA supplement; An amount of vitamin D based on the Food and Nutrition Board's Recommended Daily Allowances (RDA); UNICEF/WHO/UNU recommended amounts of remaining nutrients (UNIMMAP recommendations). The supplement is taken weekly during pre-pregnancy. 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
• Iron and Folic Acid
The doses of weekly and daily iron (60mg) and folic acid (2800µg) are based on current WHO recommendations for WRA.
• Folic Acid
It is unethical to have a placebo group as FA is universally recommended for WRA to prevent neural tube defects. Therefore, the control group will receive 2800 µg FA once a week during the pre-pregnancy period. This dosage is safe and meets the minimum recommended intake of 400 µg/d for Women of Reproductive Age (WRA). Recent studies have shown that a weekly dose of 2800 µg FA is as effective as a daily dose of 400 µg in improving folic acid and reducing homocysteine levels among WRA.

Locations

Country	Name	City	State
Vietnam	Thainguyen University of Medicine and Pharmacy	Hành Ph? Thái Nguyên	Thái Nguyên

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	Micronutrient Initiative, The Mathile Institute for the Advancement of Human Nutrition

Country where clinical trial is conducted

Vietnam, 

References & Publications (5)

Nguyen PH, DiGirolamo AM, Gonzalez-Casanova I, Pham H, Hao W, Nguyen H, Truong TV, Nguyen S, Harding KB, Reinhart GA, Martorell R, Ramakrishnan U. Impact of preconceptional micronutrient supplementation on maternal mental health during pregnancy and postp — View Citation

Nguyen PH, Gonzalez-Casanova I, Young MF, Truong TV, Hoang H, Nguyen H, Nguyen S, DiGirolamo AM, Martorell R, Ramakrishnan U. Preconception Micronutrient Supplementation with Iron and Folic Acid Compared with Folic Acid Alone Affects Linear Growth and Fine Motor Development at 2 Years of Age: A Randomized Controlled Trial in Vietnam. J Nutr. 2017 Aug;147(8):1593-1601. doi: 10.3945/jn.117.250597. Epub 2017 Jun 14. — View Citation

Nguyen PH, Lowe AE, Martorell R, Nguyen H, Pham H, Nguyen S, Harding KB, Neufeld LM, Reinhart GA, Ramakrishnan U. Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT): a randomized controlled study. BMC Public Health. 2012 Oct 24;12:898. doi: 10.1186/1471-2458-12-898. — View Citation

Nguyen PH, Young M, Gonzalez-Casanova I, Pham HQ, Nguyen H, Truong TV, Nguyen SV, Harding KB, Reinhart GA, Martorell R, Ramakrishnan U. Impact of Preconception Micronutrient Supplementation on Anemia and Iron Status during Pregnancy and Postpartum: A Rand — View Citation

Ramakrishnan U, Nguyen PH, Gonzalez-Casanova I, Pham H, Hao W, Nguyen H, Truong TV, Nguyen S, Harding KB, Reinhart GA, Neufeld LM, Martorell R. Neither Preconceptional Weekly Multiple Micronutrient nor Iron-Folic Acid Supplements Affect Birth Size and Ges — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth Size	Infants' weight, length and head circumference will be measured as early as possible within 24 hours after birth using standard procedures. All measurements will be obtained in duplicate by the same data collector. Weight-for-age and length-for-age z scores will be calculated using the 2006 WHO reference data.	At birth
Primary	Gestational Age	Gestational age will be calculated based on the date of last menstrual period. This method has been shown to be reliable in previous work and we expect precise estimates since we will be visiting women weekly from baseline during the prepregnancy period and will exclude women who may be have delivered in the past 6 months.	At birth
Primary	Child growth	Length and weight will be measured at birth, 1, 3, 6, 9, 12, 15, 18, and 24 mo	From birth through 24 months
Primary	Child development	Child development will be measured using the Bayley Scales for Infant Development III at 12 and 24 mo and the Wechsler Intelligence Scale for Children at age 6-7 y	Up to 7 years post enrollment
Primary	Weight-for-age Z score (WAZ)	Weight-for-age Z score (WAZ) in offspring of women receiving only FA, offspring of women who receive weekly pre-pregnancy IFA, and offspring of women who receive weekly MM supplements	Up to 7 years post enrollment
Primary	Height-for-age Z score (HAZ)	Height-for-age Z score (HAZ) in offspring of women receiving only FA, offspring of women who receive weekly pre-pregnancy IFA, and offspring of women who receive weekly MM supplements	Up to 7 years post enrollment
Primary	Weight -for-Height Z (WHZ) or Body Mass Index Z score (BMIZ)	Weight -for-Height Z score (WHZ) or BMIZ in offspring of women receiving only FA, offspring of women who receive weekly pre-pregnancy IFA, and offspring of women who receive weekly MM supplements	Up to 7 years post enrollment
Primary	Body composition (Lean mass/fat free mass index)	Body composition (Lean mass/fat free mass index) in offspring of women receiving only FA, offspring of women who receive weekly pre-pregnancy IFA, and offspring of women who receive weekly MM supplements	Up to 7 years post enrollment
Secondary	Mothers' iron status	Venous blood samples (5 ml) will be collected from women at: baseline, the first prenatal visit and at 1 and 3 months post partum. Anemia will be defined as Hb value <12 g/L for non-pregnant women,and <11g/L for pregnant women and infants, and iron deficiency as serum ferritin <12 µg/L (93).	At baseline and 1 and 3 months post partum
Secondary	Infants' iron status	Infant iron status will be measured in cord blood samples (5 ml) obtained at delivery and at 3 months of age using a capillary blood sample (100 l) that will be obtained from a heel prick.; The hemoglobin concentration will be measured from a drop of blood using the HEMOCUE B- Hb photometer. The blood samples will then be centrifuged and serum samples will be aliquotted into microcuvettes and handled in the same way as described for mothers. Serum ferritin and transferrin receptor concentrations will be assayed using the ELISA method.	1 and 3 months of age
Secondary	Maternal depression	Center for Epidemiological Studies Depression Scale (CES-D) and Edinburgh Postnatal Depression Scale (EPDS)	At baseline, during pregnancy, 3 months postpartum