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

NCT01732328 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2012-11-22

No results posted yet for this study

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.

Conditions

  • Lactation Bone Loss
  • Infant Bone Growth

Interventions

DIETARY_SUPPLEMENT

Calcium plus vitamin D

Sponsors & Collaborators

  • Rio de Janeiro State University

    collaborator OTHER

  • Universidade Federal do Rio de Janeiro

    lead OTHER

Principal Investigators

  • Flavia F Bezerra, DSc · Universidade do Estado do Rio de Janeiro, Brazil

  • Carmen M Donangelo, PhD · Universidade Federal do Rio de Janeiro, Brazil

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
19 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-06-30
Completion
2013-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01732328 on ClinicalTrials.gov