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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
History of Changes

November 19, 2012
November 21, 2012
July 2009
June 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01732328 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of Calcium Plus Vitamin D Supplementation on Adolescent Mother and Infant Bone Health
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

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Lactation Bone Loss
  • Infant Bone Growth
Dietary Supplement: Calcium plus vitamin D
  • 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
    Intervention: Dietary Supplement: Calcium plus vitamin D
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
76
June 2013
June 2012   (final data collection date for primary outcome measure)

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
Female
13 Years to 19 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01732328
CAAE 0002.0361.000-09, CNPq
No
Flavia Fioruci Bezerra, Rio de Janeiro State University
Federal University of Rio de Janeiro
Rio de Janeiro State University
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
Federal University of Rio de Janeiro
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP