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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Rio de Janeiro State University
Information provided by (Responsible Party):
Flavia Fioruci Bezerra, Rio de Janeiro State University
ClinicalTrials.gov Identifier:
NCT01732328
First received: November 19, 2012
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Lactation Bone Loss
Infant Bone Growth
Dietary Supplement: Calcium plus vitamin D

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • Differences in maternal bone mass changes postpartum between supplemented and placebo groups [ Time Frame: 2, 5 and 12 months postpartum ] [ Designated as safety issue: No ]
  • Differences in fetal growth and infant bone mass between supplemented and placebo groups [ Time Frame: 2nd and 3rd trimester gestation and 2 mo postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Differences in human breast milk composition (nutrients and hormones) between supplemented and placebo groups [ Time Frame: 2 months postpartum ] [ Designated as safety issue: No ]
  • Differences in maternal bone status according to vitamin D receptor (VDR) polymorphisms [ Time Frame: 2, 5 and 12 months postpartum ] [ Designated as safety issue: No ]
  • Differences in infant body composition between supplemented and placebo groups [ Time Frame: 2 months postpartum ] [ Designated as safety issue: No ]
  • Differences in changes of maternal body composition postpartum between supplemented and placebo groups [ Time Frame: 2, 5 and 12 months postpartum ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: July 2009
Estimated Study Completion Date: June 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
Inactive pill (microcrystalline cellulose and corn starch) taken daily
Active Comparator: Calcium plus vitamin D
600mg of calcium and 200 international units (IU) vitamin D taken daily
Dietary Supplement: Calcium plus vitamin D

  Eligibility

Ages Eligible for Study:   13 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732328

Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Rio de Janeiro State University
Investigators
Principal Investigator: Flavia F Bezerra, DSc Universidade do Estado do Rio de Janeiro, Brazil
Study Director: Carmen M Donangelo, PhD Universidade Federal do Rio de Janeiro, Brazil
  More Information

No publications provided by Universidade Federal do Rio de Janeiro

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Flavia Fioruci Bezerra, DSc, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT01732328     History of Changes
Other Study ID Numbers: CAAE 0002.0361.000-09, CNPq
Study First Received: November 19, 2012
Last Updated: November 21, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Calcium, Dietary
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014