Effect of Calcium Plus Vitamin D Supplementation on Adolescent Mother and Infant Bone Health

Not Applicable

• Conditions: Lactation Bone Loss; Infant Bone Growth
• Interventions: Dietary Supplement: Calcium plus vitamin D

• Registration Number: NCT01732328
• Lead Sponsor: Universidade Federal do Rio de Janeiro

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2012-06
• Status Verified: 2012-11
• Study First Submitted: 2012-11-19
• Study First Submitted QC: 2012-11-21
• Last Update Submitted: 2012-11-21
• Study First Posted: 2012-11-22
• Last Update Posted: 2012-11-22
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium plus vitamin D	Calcium plus vitamin D	600mg of calcium and 200 international units (IU) vitamin D taken daily

Primary Outcome Measures

Name	Time	Method
Differences in maternal bone mass changes postpartum between supplemented and placebo groups	2, 5 and 12 months postpartum
Differences in fetal growth and infant bone mass between supplemented and placebo groups	2nd and 3rd trimester gestation and 2 mo postpartum

Secondary Outcome Measures

Name	Time	Method
Differences in changes of bone and calcium related hormones and vitamin D status between supplemented and placebo groups	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	2 months postpartum
Differences in maternal bone status according to vitamin D receptor (VDR) polymorphisms	2, 5 and 12 months postpartum
Differences in infant body composition between supplemented and placebo groups	2 months postpartum
Differences in changes of maternal body composition postpartum between supplemented and placebo groups	2, 5 and 12 months postpartum