Overview

This trial is active, not recruiting.

Conditions lactation bone loss, infant bone growth
Treatment calcium plus vitamin d
Sponsor Universidade Federal do Rio de Janeiro
Collaborator Rio de Janeiro State University
Start date July 2009
End date June 2012
Trial size 76 participants
Trial identifier NCT01732328, CAAE 0002.0361.000-09, CNPq

Summary

Pregnancy and lactation are periods of high calcium requirement. Inadequate maternal calcium intake and vitamin D insufficiency may adversely affect fetal and neonatal growth and maternal bone mass particularly in adolescent mothers. The investigators propose to evaluate the influence of calcium plus vitamin D supplementation during pregnancy on bone mass of lactating adolescent mothers with habitually low calcium and vitamin D, on fetal growth and neonate bone mass. Mothers are randomly assigned to receive daily calcium (600 mg) plus vitamin D3 (200 IU) supplement or placebo from mid gestation until parturition. Fetal growth parameters are assessed by standard ultrasound techniques at mid and late gestation. Maternal bone mass is assessed by dual energy x-ray absorptiometry (DXA) at 2 and 5 months postpartum and 6 months after weaning. Infant bone mass is assessed by DXA at 2 months postpartum.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Placebo Comparator)
Inactive pill (microcrystalline cellulose and corn starch) taken daily
(Active Comparator)
600mg of calcium and 200 international units (IU) vitamin D taken daily
calcium plus vitamin d

Primary Outcomes

Measure
Differences in maternal bone mass changes postpartum between supplemented and placebo groups
time frame: 2, 5 and 12 months postpartum
Differences in fetal growth and infant bone mass between supplemented and placebo groups
time frame: 2nd and 3rd trimester gestation and 2 mo postpartum

Secondary Outcomes

Measure
Differences in changes of bone and calcium related hormones and vitamin D status between supplemented and placebo groups
time frame: 2nd and 3rd trimester of pregnancy and 2, 5, 12 mo postpartum
Differences in human breast milk composition (nutrients and hormones) between supplemented and placebo groups
time frame: 2 months postpartum
Differences in maternal bone status according to vitamin D receptor (VDR) polymorphisms
time frame: 2, 5 and 12 months postpartum
Differences in infant body composition between supplemented and placebo groups
time frame: 2 months postpartum
Differences in changes of maternal body composition postpartum between supplemented and placebo groups
time frame: 2, 5 and 12 months postpartum

Eligibility Criteria

Female participants from 13 years up to 19 years old.

Inclusion Criteria: - 13-19 y old - between 23 and 29 wk of gestation - primiparous - carrying single fetus - intending to exclusively or predominantly breastfeed Exclusion Criteria: - chronic health problems - smokers - users of nutritional supplements, except iron supplements provided during standard prenatal care

Additional Information

Official title Calcium Plus Vitamin D Supplementation During Pregnancy of Adolescent Mothers: Effects on Maternal and Infant Bone Mass, Calcium and Bone Metabolism and Breast Milk Composition
Principal investigator Flavia F Bezerra, DSc
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Universidade Federal do Rio de Janeiro.