Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568315
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Co-administration of Calcium and Multiple Micronutrient Supplements for Maternal and Newborn Hemoglobin and Iron Status A Randomized Non-inferiority Trial in Burkina Faso and Pakistan
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CaMMS
Brief Summary:
The World Health Organization WHO currently recommends the pregnant women receive iron-containing supplements and in settings where calcium intake is low calcium supplements Supplements are to be taken at two separate times of the day as calcium may interfere with iron absorption The goal of this clinical trial is to learn whether taking daily calcium supplements and iron-containing multiple micronutrient supplements together at the same time has any negative impact on the hemoglobin or iron status of pregnant women or the womans infants Participants will be randomly assigned and counseled to either take the supplements together every morning or to take the multiple micronutrient supplement in the morning and the calcium supplement in the evening Participants will visit the antenatal clinic monthly and be asked to provide a blood sample in early mid and late pregnancy Researchers will also take blood samples from infants at the time of birth
Detailed Description:
Women of reproductive age in low-and-middle-income countries typically consume diets inadequate in many micronutrients Resulting micronutrient deficiencies are further exacerbated during pregnancy by the increased demands of the developing fetus Studies show that antenatal micronutrient supplementation can have important benefits for maternal and infant health While WHO currently recommends daily iron and folic acid supplementation many countries are transitioning to multiple micronutrient supplementation MMS based on evidence of its further benefit in reducing risk of low birth weight small-for-gestational age births stillbirths and preterm delivery WHO also recommends calcium supplementation for women in settings where calcium intake is low to reduce high blood pressure and prevent preeclampsia and preterm birth
Women are instructed to take calcium supplements separately from iron-containing supplements to avoid any negative impact of calcium on iron absorption However evidence that calcium limits iron absorption is largely from studies of single test meals Research on the longer-term implications of consuming the two nutrients together for iron status and hemoglobin is limited particularly in pregnancy This is an important research question as limiting the number of times per day that a woman needs to take supplements is likely to improve adherence to the regimen There is also interest in designing a new MMS formulation that includes calcium such that women could take a single tablet daily
This individually randomized controlled non-inferiority trial will enroll 1600 women in both Burkina Faso and Pakistan to assess the impact of co-administering calcium 500 mg elemental calcium as calcium carbonate and multiple micronutrient supplements including 30 mg elemental iron compared with the currently recommended practice of taking the supplements at two separate times of the day on hematological and iron status of pregnant women and the womens infants The sample size is based on a non-inferiority margin of -30 gL 90 power a one-sided α0025 a standard deviation of 17 gL for the primary hemoglobin outcome and 15 loss to follow-up
Potentially eligible women will be identified through antenatal care visits in Burkina Faso and household visits in Pakistan For those who consent to screening research staff will measure hemoglobin and conduct a fetal ultrasound exam Inclusion and exclusion criteria are provided below Research staff will obtain written documentation of informed consent
At enrollment women will be randomized and research staff will collect socio-demographic data take anthropometric and blood pressure measurements and collect a venous blood sample Women will receive counseling based on the randomly assigned intervention and be given a supply of study supplements Research staff will see women monthly at antenatal visits to collect information on adherence by recall and pill count side effects signssymptoms of anemia and information on any iron treatment that women may have received between visits Iron treatment prescribed by providers outside of the trial will also be abstracted from medical records At the mid-pregnancy 2024 weeks and late pregnancy 3034 weeks visits research staff will take hemoglobin HemoCue anthropometric and blood pressure measurements and collect venous blood samples Women with severe anemia 70 gL will be referred for treatment Within 72 hours of birth research staff will collect a heel prick blood sample from infants Blood samples will be processed at antenatal clinics and transferred to central laboratories for measurement of hematological parameters iron status and inflammation
Women are instructed to take calcium supplements separately from iron-containing supplements to avoid any negative impact of calcium on iron absorption However evidence that calcium limits iron absorption is largely from studies of single test meals Research on the longer-term implications of consuming the two nutrients together for iron status and hemoglobin is limited particularly in pregnancy This is an important research question as limiting the number of times per day that a woman needs to take supplements is likely to improve adherence to the regimen There is also interest in designing a new MMS formulation that includes calcium such that women could take a single tablet daily
This individually randomized controlled non-inferiority trial will enroll 1600 women in both Burkina Faso and Pakistan to assess the impact of co-administering calcium 500 mg elemental calcium as calcium carbonate and multiple micronutrient supplements including 30 mg elemental iron compared with the currently recommended practice of taking the supplements at two separate times of the day on hematological and iron status of pregnant women and the womens infants The sample size is based on a non-inferiority margin of -30 gL 90 power a one-sided α0025 a standard deviation of 17 gL for the primary hemoglobin outcome and 15 loss to follow-up
Potentially eligible women will be identified through antenatal care visits in Burkina Faso and household visits in Pakistan For those who consent to screening research staff will measure hemoglobin and conduct a fetal ultrasound exam Inclusion and exclusion criteria are provided below Research staff will obtain written documentation of informed consent
At enrollment women will be randomized and research staff will collect socio-demographic data take anthropometric and blood pressure measurements and collect a venous blood sample Women will receive counseling based on the randomly assigned intervention and be given a supply of study supplements Research staff will see women monthly at antenatal visits to collect information on adherence by recall and pill count side effects signssymptoms of anemia and information on any iron treatment that women may have received between visits Iron treatment prescribed by providers outside of the trial will also be abstracted from medical records At the mid-pregnancy 2024 weeks and late pregnancy 3034 weeks visits research staff will take hemoglobin HemoCue anthropometric and blood pressure measurements and collect venous blood samples Women with severe anemia 70 gL will be referred for treatment Within 72 hours of birth research staff will collect a heel prick blood sample from infants Blood samples will be processed at antenatal clinics and transferred to central laboratories for measurement of hematological parameters iron status and inflammation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None